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PubMed1997

An in-flight investigation of the efficacy of dextroamphetamine for sustaining helicopter pilot performance.

A promising countermeasure for fatigue in sustained aviation operations is stimulant administration. However, well-controlled, aviation-relevant studies of the efficacy of medications such as Dexedrine are virtually nonexistent. In this investigation, flight performance, mood, and alertness were evaluated in 10 UH-60 pilots during sleep deprivation periods under Dexedrine or placebo. Relative to placebo, Dexedrine improved flight performance during straight-and-levels, climbs, descents, right turns, and a left-descending turn, with tendencies toward better performance during the left turns and the instrument landing system approach. Dexedrine markedly reduced subjective feelings of fatigue, confusion, and depression while increasing feelings of vigor. Central nervous system arousal was enhanced by Dexedrine relative to placebo. No significant side effects occurred, although Dexedrine was associated with mild asymptomatic increases in heart rate and BP. Thus, Dexedrine appears effective for the short-term sustainment of aviator performance during sustained operations. However, future work should investigate the efficacy of stimulants for longer-term use (e.g., more than 40 h of continuous wakefulness).

Adult↗
PubMed2001

Placebo-controlled evaluation of amphetamine mixture-dextroamphetamine salts and amphetamine salts (Adderall): efficacy rate and side effects.

OBJECTIVE: The primary objective of this study was to determine the efficacy rate of Adderall in children newly diagnosed with attention-deficit/hyperactivity disorder (ADHD). A secondary objective was to address the severity of side effects associated with Adderall treatment in children with ADHD using the Barkley Side Effects Questionnaire (BSEQ). DESIGN: Randomized, double-blind, placebo-controlled crossover trial. SETTING: A large rural tertiary care clinic. PATIENTS: Participants were prospectively recruited from children 5 to 18 years of age referred for academic and/or attention problems; 154 children who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for ADHD were enrolled. Interventions. Two doses of Adderall (0.15 mg/kg/dose and 0.3 mg/kg/dose) were compared with placebo in separate 2-week trials. Participants received each dosage regimen twice daily for 7 consecutive days. MEASUREMENTS AND MAIN RESULTS: Efficacy rates were determined by comparing Adderall with placebo during the low-dose crossover sequence and also during the high-dose crossover sequence. The criteria that defined a positive response to Adderall relative to placebo (with each patient serving as their own control) included an indication of response by at least 1 of 2 parent measures of children's behavior or at least 2 of 5 teacher measures of children's behavior. The Adderall efficacy rate was determined based on parent criteria alone, teacher criteria alone, and by a more stringent definition of response that required concurrence between parent and teacher criteria. The Adderall response rate in this study ranged from 59% when requiring concurrence between parent and teacher observers, to 82% when based on parent criteria alone. Overall, 137 of 154 participants (89%) showed a positive response by either the parent or teacher response criteria. Parents completed a modified version of the BSEQ during each week of the trial. Appetite, stomachaches, and insomnia were rated as worse by parents while children were receiving either dose of Adderall; headaches were rated as worse when children were receiving the higher dose of Adderall. Parents rated certain side effects, including staring/daydreaming, sadness, euphoria, and anxious/irritable, as worse during placebo regimens. CONCLUSIONS: We found that Adderall is highly efficacious in our population of youth diagnosed with ADHD. In addition, Adderall is well-tolerated with a side effect profile similar to that reported for other psychostimulants.

Adolescent↗
PubMed2001

A double-blind, placebo-controlled study of the use of amphetamine in the treatment of aphasia.

BACKGROUND AND PURPOSE: A number of studies suggest that drugs which increase the release of norepinephrine promote recovery when administered late (days to weeks) after brain injury in animals. A small number of clinical studies have investigated the effects of the noradrenergic agonist dextroamphetamine in patients recovering from motor deficits following stroke. To determine whether these findings extend to communication deficits subsequent to stroke, we administered dextroamphetamine, paired with speech/language therapy, to patients with aphasia. METHODS: In a prospective, double-blind study, 21 aphasic patients with an acute nonhemorrhagic infarction were randomly assigned to receive either 10 mg dextroamphetamine or a placebo. Patients were entered between days 16 and 45 after onset and were treated on a 3-day/4-day schedule for 10 sessions. Thirty minutes after drug/placebo administration, subjects received a 1-hour session of speech/language therapy. The Porch Index of Communicative Ability was used at baseline, at 1 week off the drug, and at 6 months after onset as the dependent language measure. RESULTS: Although there were no differences between the drug and placebo groups before treatment (P=0.807), by 1 week after the 10 drug treatments ended there was a significant difference in gain scores between the groups (P=0.0153), with the greater gain in the dextroamphetamine group. The difference was still significant when corrected for initial aphasia severity and age. At the 6-month follow-up, the difference in gain scores between the groups had increased; however, the difference was not significant (P=0.0482) after correction for multiple comparisons. CONCLUSIONS: Administration of dextroamphetamine paired with 10 1-hour sessions of speech/language therapy facilitated recovery from aphasia in a small group of patients in the subacute period after stroke. Neuromodulation with dextroamphetamine, and perhaps other drugs that increase central nervous system noradrenaline levels, may facilitate recovery when paired with focused behavioral treatment.

Adrenergic Uptake Inhibitors↗
PubMed1979

Effects of dopamine agonists and antagonists in Tourette's disease.

The actions of haloperidol, dextroamphetamine sulfate, levamfetamine succinate, apomorphine, and piribedil were studied in two patients with Giles de la Tourette's disease in an attempt to clarify the catecholamine mechanisms involved in this condition. Both dextroamphetamine and levamfetamine increased the severity of the symptoms; dextroamphetamine was more potent. Haloperidol controlled the symptoms and also antagonized the effect of dextroamphetamine. Apomorphine injections reduced the severity of symptoms, even in the presence of dextroamphetamine. We conclude that dopamine rather than norepinephrine is the principal catecholamine responsible for the symptoms. The effect of apomorphine may be understood through its action on postulated presynaptic inhibitory dopamine receptors, or other presynaptic mechanisms of action.

Adolescent↗
PubMed2005

Functional neuroanatomical substrates of altered reward processing in major depressive disorder revealed by a dopaminergic probe.

CONTEXT: The pathophysiology of major depressive disorder (MDD) includes disturbances in several neuroanatomical substrates and neurotransmitter systems. The challenge is to elucidate the brain mechanisms of MDD behavioral symptoms, chiefly those of anhedonia. OBJECTIVES: To visualize the neuroanatomical substrates implicated in altered reward processing in MDD, using functional magnetic resonance imaging in combination with a dopaminergic probe (a 30-mg dose of oral dextroamphetamine sulfate) to stimulate the brain reward system; and to test the hypothesis that a hypersensitive response to dextroamphetamine in MDD involves the prefrontal cortex and the striatum. DESIGN AND INTERVENTIONS: Among subjects with MDD and healthy control subjects, functional magnetic resonance imaging data were collected before and after single-blind administration of dextroamphetamine. SETTING: Subjects were recruited through local newspaper advertisements and by word of mouth. PARTICIPANTS: Twelve depressed subjects (mean age, 34.83 years; male-female ratio, 6:6) met criteria for MDD according to the DSM-IV, were not taking antidepressants, and had no comorbid Axis I disorders. Twelve control subjects (mean age, 29.33 years; male-female ratio, 5:7) were healthy volunteers without a history of Axis I disorders. MAIN OUTCOME MEASURES: Functional magnetic resonance imaging blood oxygen level-dependent activation was measured during a controlled task, and dextroamphetamine-induced subjective effects were assessed using the Addiction Research Center Inventory. RESULTS: Subjects with MDD had a hypersensitive response to the rewarding effects of dextroamphetamine (2-fold increase; t(21) = 2.74, P = .01), with altered brain activation in the ventrolateral prefrontal cortex and the orbitofrontal cortex and the caudate and putamen (F(1,44) = 11.93, P = .001). CONCLUSION: Dopamine-related neuroanatomical substrates are involved in altered reward processing in MDD, shedding light on the neurobiology of the anhedonic symptoms in MDD and suggesting these substrates as future therapeutic targets.

Adult↗
PubMed2001

Double-blind, placebo-controlled study of single-dose amphetamine formulations in ADHD.

OBJECTIVE: To compare the efficacy and time course of single morning doses of Adderall, extended-release, and immediate-release dextroamphetamine sulfate. METHOD: Thirty-five children with attention-deficit/hyperactivity disorder, combined type, were given Adderall, immediate-release dextroamphetamine, dextroamphetamine Spansules, and placebo in a randomized, double-blind, crossover study. Behavior ratings, locomotor activity measurements, and academic measures were obtained over a period of 8 weeks. RESULTS: All three drugs exhibited robust efficacy versus placebo on nearly all measures. The effects of dextroamphetamine Spansules were less robust in the morning, particularly compared with Adderall, but they lasted 3 to 6 hours longer, depending on the measure. Although parent behavior ratings and locomotor activity showed improvements up to 12 hours after single doses of all three drugs, the number of math problems attempted and completed correctly 4 hours after dosing were only robustly increased by Spansules. CONCLUSIONS: Both immediate-release amphetamines demonstrated earlier onset of effects, but dextroamphetamine Spansules showed more sustained effects that were present on a wider range of measures.

Amphetamines↗
PubMed1990

Stimulant drug treatment of hyperactivity: biochemical correlates.

To compare the effects of the stimulant drugs dextroamphetamine and methylphenidate on urinary and plasma monoamines and metabolites within the same clinical sample, thirty-one children with attention-deficit disorder with hyperactivity were treated with dextroamphetamine (up to 1.5 mg/kg/day), methylphenidate (up to 3.0 mg/kg/day), and placebo in an 11-week double-blind crossover trial. As expected, both drugs showed striking clinical efficacy, and within a subsample of the group, earlier findings were confirmed, that dextroamphetamine but not methylphenidate lowered urinary and plasma 3-methoxy-4-hydroxyphenylglycol and whole body norepinephrine turnover, and that urinary and plasma concentration of homovanillic acid was unaltered by either drug. Methylphenidate but not dextroamphetamine increased plasma norepinephrine. Urinary epinephrine and metanephrine were increased with both drugs, but this increase did not correlate significantly with clinical improvement.

3,4-Dihydroxyphenylacetic Acid↗
PubMed1998

Sibutramine: a new weight loss agent without evidence of the abuse potential associated with amphetamines.

Sibutramine is a serotonin and norepinephrine reuptake inhibitor that has shown efficacy as a weight loss and weight maintenance agent. Because of the abuse liability and physical dependence potential of amphetamines and related antiobesity agents, this study evaluated the abuse potential of sibutramine and compared it with that of dextroamphetamine and placebo in recreational stimulant users. Thirty-one male recreational stimulant users participated in this single-site, Latin square crossover study that compared the effects of two doses of sibutramine (20 mg and 30 mg) to dextroamphetamine (20 mg and 30 mg) and placebo, using a series of validated subjective scales or questionnaires. For scales measuring stimulation and euphoria, there was a greater mean response for dextroamphetamine 30 mg versus 20 mg, with both doses having a significantly greater stimulant and euphoric effect than placebo at the majority of time points (p < 0.05); responses for both doses of sibutramine were statistically indistinguishable from placebo at all time points. Responses to "street value" and "most enjoyed study session" questions confirmed that sibutramine lacks abuse potential; mean cash value estimates of street value were significantly greater for both dextroamphetamine doses than for placebo or either sibutramine doses (p < 0.05), and the rank order of session enjoyment placed both doses of sibutramine last. Together with the relatively late Tmax of the active metabolites (3-4 hours), this short-term, single-dose study provides strong evidence that sibutramine does not have the potential for abuse that is characteristic of amphetamines and that it is indistinguishable from placebo in abuse potential.

Adult↗
PubMed2001

The influence of stimulants, sedatives, and fatigue on tunnel vision: risk factors for driving and piloting.

A computerized task was used in two studies to examine the influence of stimulants, sedatives, and fatigue on single-target and divided-attention responses in different parts of the visual field. The drug effects were evaluated over time with repeated behavioral and subjective measures against ascending and descending drug levels. In the first study, 18 fully rested participants received placebo, alprazolam (0.5 mg), and dextroamphetamine (10 mg). Alprazolam impairs performance, whereas dextroamphetamine induces enhancement and tunnel vision. Study 2 exposed 32 participants to fatigue and no fatigue with a repeated-measures crossover design. Four independent groups subsequently received placebo, dextroamphetamine (10 mg), caffeine (250 mg), or alcohol (.07%). Under fatigue, stimulants have no performance-enhancing effects, whereas impairment from alcohol is severe. Under no fatigue, alcohol has a modest effect, caffeine has no effect, and dextroamphetamine significantly enhances divided-attention performance coincident with tunnel vision. Participants rate all drug effects more stimulating and less sedating while fatigued. Implications for transportation safety are discussed. Actual or potential applications of this research include driver and pilot training.

Alcohol Drinking↗
PubMed1980

Double-blind evaluation of reinforcing and anorectic actions of weight control medications. Interaction of pharmacological and behavioral treatments.

Within a behavioral self-management treatment program for overweight, 59 patients were randomly assigned to receive as an adjunct either dextroamphetamine sulfate, fenfluramine hydrochloride, or placebo in a double-blind procedure. Patients self-regulated their drug intake during a four-week medication period. Two types of behavioral-pharmacological interaction were observed: (1) drug assignment influenced participation in the behavioral treatment; and (2) drug assignment influenced the extent of medication self-administration. The dextroamphetamine group was superior in terms of behavioral treatment participation, extent of eating and exercise habit change, and weight loss. Self-administration of dextroamphetamine was most well-maintained--showing it to be a reinforcer--and self-administration of fenfluramine was suppressed below placebo levels. No patient taking either drug showed excessive drug intake, and all were, in fact, conservative in drug use. These data concerning relative reinforcing efficacy within a therapeutic medication setting are discussed in relation to data from animal models used to assess relative abuse liability of these drugs.

Adult↗
PubMed1983

A naturalistic assessment of the motor activity of hyperactive boys. II. Stimulant drug effects.

Twenty-four-hour motor activity was assessed in a naturalistic setting in 12 hyperactive boys for four weeks (672 consecutive hours). Dextroamphetamine, 15 mg/day, or placebo was administered on alternate weeks, using a double-blind ABAB design. When the boys received dextroamphetamine, motor activity was significantly decreased for about eight hours after drug administration. This decrease was followed by a period of slight but significant increases in activity ("rebound"). Dextroamphetamine decreased activity most strikingly during structured classroom activity; during physical education, however, there was a significant drug-induced increase in motor activity.

Attention Deficit Disorder with Hyperactivity↗
PubMed1985

Treatment of hyperactive children with monoamine oxidase inhibitors. II. Plasma and urinary monoamine findings after treatment.

Urinary monoamines and metabolites as well as plasma norepinephrine (NE) and 3-methoxy-4-hydroxyphenylglycol were measured in 14 boys (mean age, 9.2 years) with Attention Deficit Disorder With Hyperactivity during an initial placebo period, after four weeks of treatment with either dextroamphetamine sulfate (N=5) or a monoamine oxidase inhibitor (N=9) and at the end of a subsequent two-week placebo "washout" period. Both dextroamphetamine and monoamine oxidase inhibitors produced persistent changes in monoamines and metabolites, which were most marked and consistent for NE and its metabolite 3-methoxy-4-hydroxyphenylglycol. These changes did not correlate in a consistent fashion with clinical response during drug treatment. Moreover, there was rapid clinical relapse following cessation of either treatment while the alterations in NE metabolism remained during the two weeks following drug, further demonstrating the independence of these changes from clinical state. Future studies with dextroamphetamine need drug-free periods that are greater than 14 days to obtain true "baseline" conditions.

Amines↗
PubMed1994

Evaluation of treatment with stimulants in narcolepsy.

This paper briefly reviews sleep laboratory studies on the treatment efficacy of methylphenidate, pemoline, dextroamphetamine and methamphetamine. The literature indicates that 1) methylphenidate, dextroamphetamine, pemoline and methamphetamine objectively improve somnolence as measured by the Multiple Sleep Latency or Maintenance of Wakefulness Tests (MSLT or MWT); 2) pemoline, at doses up to 112.5 mg, is less effective in controlling somnolence than methylphenidate, dextroamphetamine and methamphetamine; 3) there are dose-dependent improvements in performance that parallel MSLT and MWT data; and 4) at the highest doses of stimulants studied to date, narcoleptics, although improved, still did not function on MSLT or MWT and most performance tests at levels comparable to those of control subjects. Future research designs should address issues of placebo effect, practice effects and the degree to which alertness and performance measures can be pharmacologically brought up to levels comparable to those of normal control subjects.

Adult↗
PubMed1999

ADHD in girls: clinical comparability of a research sample.

OBJECTIVE: The investigation of attention-deficit/hyperactivity disorder (ADHD) in girls raises complex questions of referral bias and selection criteria. The authors sought to determine whether they could recruit a research sample of comparably affected girls using a combination of sex-independent diagnostic criteria and sex-normed cutoffs on teacher ratings. They also report on the largest placebo-controlled crossover comparison of methylphenidate and dextroamphetamine in girls with ADHD. METHOD: Subjects were 42 girls with DSM-III-R/DSM-IV ADHD (combined type) contrasted to 56 previously studied boys with ADHD on comorbid diagnoses, behavioral ratings, psychological measures, psychiatric family history, and stimulant drug response. RESULTS: Girls with ADHD were statistically indistinguishable from comparison boys on nearly all measures. Girls exhibited robust beneficial effects on both stimulants, with nearly all (95%) responding favorably to one or both drugs in this short-term trial. Dextroamphetamine produced significantly greater weight loss than methylphenidate. CONCLUSIONS: This highly selected group of ADHD girls was strikingly comparable with comparison boys on a wide range of measures. The results confirm that girls with ADHD do not differ from boys in response to methylphenidate and dextroamphetamine and that both stimulants should be tried when response to the first is not optimal.

Analysis of Variance↗
PubMed1995

Amphetamine paired with physical therapy accelerates motor recovery after stroke. Further evidence.

BACKGROUND AND PURPOSE: In animal models of brain injury, administration of numerous pharmaceuticals is reported to facilitate functional recovery. However, only drugs that increase the release of norepinephrine have been shown to promote recovery when administered late (days to weeks) after injury. To determine whether these findings were applicable to humans, we administered the norepinephrine stimulant dextroamphetamine, paired with physical therapy, to hemiplegic stroke patients. METHODS: Ten hemiplegic patients who suffered an acute ischemic infarction were entered between days 16 and 30 after onset and randomly assigned to receive either 10 mg of dextroamphetamine or a placebo orally every fourth day for 10 sessions paired with physical therapy. The Fugl-Meyer Motor Scale was used at baseline, within each session, and for 12 months after onset as the dependent measure. Confounding medications such as alpha-adrenergic antagonists or agonists were excluded in all subjects. RESULTS: Although there were no differences between the groups at baseline (P = .599), there was a significant (P = .047) difference between the groups when the drug had been discontinued for 1 week and at the 12-month follow-up visit (P = .047). CONCLUSIONS: Administration of dextroamphetamine paired with physical therapy increased the rate and extent of motor recovery in a small group of hemiplegic stroke patients. These data support and extend previous findings of the facilitatory aspects of certain types of drugs on recovery from brain injury. The use of neuromodulation may allow the nervous system to adapt previously unused or alternative pathways to relevant external input.

Administration, Oral↗
PubMed1998

Spontaneous dyskinesia in subjects with schizophrenia spectrum personality.

OBJECTIVE: The study of spontaneous dyskinesia in schizophrenia is confounded by the widespread use of neuroleptics. The authors hypothesized that spontaneous dyskinesia would be present in subjects with schizophrenia spectrum personality (schizoid, paranoid, or schizotypal). They also tested the hypothesis that dyskinetic-like movements would increase after repeated dextroamphetamine challenge to the dopaminergic system. METHOD: Dyskinetic-like movements were assessed in 34 spectrum subjects and 22 normal subjects; nine subjects from each group were administered both placebo and repeated dextroamphetamine challenges. RESULTS: Spectrum subjects had more dyskinetic-like movements than normal subjects. Spontaneous dyskinesia was present in 12% of the spectrum subjects but was not seen in the normal subjects. Subjects with schizotypal personality had more dyskinetic-like movements than subjects with schizoid personality or normal subjects. Dyskinesia was present in 24% of the schizotypal subjects but not in the other groups. Dyskinetic movement scores correlated with positive symptom scores. With repeated amphetamine challenge, normal subjects showed a pattern of behavioral sensitization (an increase in dyskinetic-like movements), but spectrum subjects showed an abnormal response (fewer dyskinetic-like movements). CONCLUSIONS: Dyskinesia and dyskinetic-like movements are more common in subjects with schizophrenia spectrum personality (primarily schizotypal) than in normal subjects and are related to positive symptoms. A failure of normal behavioral sensitization mechanisms after dextroamphetamine challenge is seen in subjects with schizophrenia spectrum personality.

Comorbidity↗
PubMed1984

Qualitative measurement of drugs.

It has been noted for several years that certain drugs produce abnormal test results in patients who are administered the electronystagmograph (ENG) test. Drug specific waveforms, termed drug evoked potentials (DEP), have been identified by using the ENG for alcohol, marijuana, cocaine, tranquilizers, amphetamines, barbiturates, opiates, hallucinogens, caffeine, aminophylline, dopamine, several gases and approximately 75 combinations of drugs (N = 821). Tests for double blind diagnosis of drug intake as well as tests for repeatability within the same subject were conducted. Subjects included surgical candidates, healthy volunteers, and neonates (N = 248). Drugs tested were ketamine hydrochloride, fentanyl, sodium pentothal, cocaine, dextroamphetamine, sodium seconal, morphine sulfate, phenobarbital, and meperidine. Placebos of dextrose in water and sucrose tablets were also used (N = 25). Analysis of the waveforms produced by surgical candidates and healthy volunteers revealed no false negatives or false positives. Analysis of waveforms produced by neonates whose mothers had been administered meperidine demonstrated a diminishing effect over the course of a 3 day period. Results of repeated studies revealed reliability within subject. One subject who was administered dextroamphetamine did not produce a wave consistent with amphetamine with a dosage of 5 mg. He did, however, produce an amphetamine wave when administered 10 mg of dextroamphetamine. These findings suggest a dose related effect, indicating the need for establishment of minimal levels of detection. Results indicate that with refinement and further research, this method could be used for identification of drugs diagnostically.

Adult↗