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Dextroamphetamine for Cocaine-Dependence Treatment: A Double-Blind Randomized Clinical Trial
Abstract
A properly implemented agonist treatment regimen should improve retention and reduce illicit drug use. Cocaine-dependent subjects (N = 128) were enrolled in a 12-week randomized, double-blind, placebo-controlled trial. In the multistage dosing design, subjects initially received placebo (PBO) or 15 to 30 mg of dextroamphetamine sulfate, sustained-release capsules. At week 5, the dose doubled to 30 mg or 60 mg for active groups. Subjects attended the clinic twice a week, provided urine samples, obtained medication, and had one behavioral therapy session a week. Retention was best for the 15- to 30-mg group, whereas the proportion of benzoylecgonine-positive urine screens was, from lowest to highest, 30 to 60 mg, 15 to 30 mg, and PBO at study end. Dosing must be refined. The results provide support for additional examination of the agonist model in psychostimulant-dependence treatment.
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Among homeless and unstably housed women in San Francisco, 47% reported cocaine or methamphetamine use in the past 6 months, and 14% of those who did not use stimulants at baseline initiated stimulant use within 6 months.
“Among homeless and unstably housed women in San Francisco, 47% reported use of cocaine or methamphetamine in the past 6 months, and 14% of those who did not use stimulants at baseline initiated stimulant use within 6 months.231”
From The ASAM/AAAP Clinical Practice Guideline on the Management of Stimulant Use Disorder (2024) · cites this paper as [231]
Dextroamphetamine is an effective treatment for amphetamine abuse.
“Dextroamphetamine causes release of DA (as well as norepinephrine and serotonin) and is an effective treatment for amphetamine abuse [181].”
From Reward circuitry dysfunction in psychiatric and neurodevelopmental disorders and genetic syndromes: animal models and clinical findings (2012) · cites this paper as [181]
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“Finally, we evaluated the effect of acute and chronic treatment with d-amphetamine, an indirect monoamine agonist that has been found to reduce cocaine intake under some conditions in clinical and preclinical studies, including using a cocaine versus food choice assay in rhesus monkeys (Macaca mulatta) (Grabowski et a…”
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“Several clinical studies have reported promising results with d-amphetamine in the treatment of stimulant abuse (Fleming and Roberts 1994; Charnaud and Griffiths 1998; White 2000; Grabowski et al. 2001; Shearer et al. 2001), and recent preclinical studies parallel these clinical findings.”
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“This approach has been explored for the treatment of cocaine dependence (Alim et al., 1995; Grabowski et al., 1997, 2001; Kampman et al., 2000; Walsh et al., 2000).”
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“Worth noting is that doses of D-amphetamine higher than tested in the present experiment are needed to reduce cocaine-taking behavior in clinical trials.(30) Intranasal cocaine produced prototypical subject-rated drug effects (eg, increased ratings of good effects).”
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BackgroundThe Self-Medication Hypothesis and Psychostimulant Treatment of Cocaine Dependence: An Update
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“Early clinical studies showed that d-amphetamine improved retention in treatment and reduced illicit cocaine use (Grabowski et al., 2001).”
BackgroundMethodNew horizons for therapeutics in drug and alcohol abuse
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“In addition, amphetamine maintenance decreased cocaine vs money choice in human laboratory studies (Greenwald et al, 2010; Rush et al, 2010), and cocaine use by patients in placebo-controlled double-blind clinical trials (Grabowski et al, 2001; Mariani et al, 2012).”
BackgroundSustained release methylphenidate for the treatment of ADHD in amphetamine abusers: A pilot study
Konstenius, M., Jayaram-Lindström, N., Beck, O., & Franck, J. (2010) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2009.11.006 · Cited by 83
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“(Grabowski et al., 2001; Grabowski, Shearer et al., 2004) showed that a slow-release formulation of d-amphetamine is effective in maintaining cocaine addicts in treatment and reducing illicit cocaine use.”
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“A recent report by Grabowski and colleagues [59] demonstrated a significant difference in benzoylecgoninepositive urines following treatment with a sustained-release preparation of d-amphetamine compared to placebo in cocaine-dependent subjects (Table 3).”
BackgroundSchmitz, J. M., Rathnayaka, N. S., Green, C., Moeller, F., Dougherty, A., & Grabowski, J. (2012) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2012.00077 · Cited by 61
“Two such medications, each showing initial positive outcomes, dextroamphetamine (Grabowski et al., 2001, 2004) and modafinil (Dackis et al., 2005; Anderson et al., 2009), but each having different dopamine-enhancing mechanisms, were expected to produce more powerful treatment effects when given in…”
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“The maximum dose in this study (60 mg/day) exceeded the dose of 40 mg/day in the laboratory study by Rush et al (2010) but matched the upper dose in two clinical trials (Grabowski et al , 2001, 2004a).”
InfluentialTherapeutic Potential of Monoamine Transporter Substrates
Rothman, R. B., & Baumann, M. H. (2006) · Current Topics in Medicinal Chemistry · doi:10.2174/156802606778249766 · Cited by 63
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“To date, three double-blind randomized trials have provided promising clinical evidence that D-amphetamine may reduce cocaine intake and/or craving in cocaine-dependent individuals (Grabowski et al. 2001; Grabowski et al. 2004a; Shearer et al. 2003).”
Agonist Replacement for Stimulant Dependence: A Review of Clinical Research
Stoops, W. W., & Rush, C. (2013) · Current pharmaceutical design · doi:10.2174/138161281940131209142843 · Cited by 65
Bisaga, A. M., Aharonovich, E., Cheng, W. Y., LEVIN, F. R., Mariani, J. J., Raby, W. N., & Nunes, E. V. (2010) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2010.04.006 · Cited by 59
“Some clinical trials have suggested that medications have greater efficacy in more homogeneous subsets of patients, such as those differing in the baseline level of use (Bisaga et al., 2006; Elkashef et al., 2008; Grabowski et al., 2001; Shoptaw et al., 2008) or the existence of comorbid conditions (Anderson et al.”
BackgroundCzoty, P., Gould, R., Martelle, J. L., & Nader, M. (2010) · Neuropsychopharmacology · doi:10.1038/npp.2010.185 · Cited by 62
“…have supported the safety and efficacy of d -amphetamine as a treatment for cocaine dependence (e.g., Fleming and Roberts 1994; White 2000), including three double-blind, placebo-controlled studies that used a sustained-release preparation (Grabowski et al., 2001, 2004b; Shearer et al., 2003).”
Shorter, D. I., Domingo, C. B., & Kosten, T. R. (2014) · Expert Opinion on Emerging Drugs · doi:10.1517/14728214.2015.985203 · Cited by 61
Pharmacotherapy of Addictive Disorders
Ross, S., & Peselow, E. D. (2009) · Clinical Neuropharmacology · doi:10.1097/wnf.0b013e3181a91655 · Cited by 57
“A final replacement approach involves substituting amphetamine for cocaine as agonist therapy where dextroamphetamine has been shown to reduce cocaine use in cocainedependent humans.(136,137) This would be similar to replacing heroin with methadone as amphetamine has a longer half-life than cocaine but still has addic…”
MethodPrisinzano, T. E. (2008) · Journal of Natural Products · doi:10.1021/np8005748 · Cited by 57
Monoamine Transporter Inhibitors and Substrates as Treatments for Stimulant Abuse
Howell, L. L., & Negus, S. S. (2014) · Advances in pharmacology · doi:10.1016/b978-0-12-420118-7.00004-4 · Cited by 56
“Clinical trials (Grabowski et al., 2001; Mariani et al., 2012) and drug self-administration studies in humans (Greenwald, Lundahl, & Steinmiller, 2010; Rush, Stoops, Sevak, & Hays, 2010), nonhuman primates (Czoty, Martelle, Garrett, & Nader, 2008; Negus, 2003; Negus & Mello, 2003a, 2003b), and rats…”
Amphetamine Reverses Escalated Cocaine Intake via Restoration of Dopamine Transporter Conformation
Siciliano, C. A., Saha, K., Calipari, E. S., Fordahl, S. C., Chen, R., Khoshbouei, H., & Jones, S. R. (2017) · Journal of Neuroscience · doi:10.1523/jneurosci.2604-17.2017 · Cited by 55
“Amphetamine (AMPH) has shown efficacy in reducing cocaine intake in human addicts in multiple clinical trials (Grabowski et al., 2001, 2004; Rush and Stoops, 2012; Nuijten et al., 2016).”
BackgroundLevin, F. R., Mariani, J. J., Pavlicova, M., Choi, C. J., Mahony, A. L., Brooks, D. J., Bisaga, A., Dakwar, E., Carpenter, K. M., Naqvi, N., et al. (2020) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2019.107700 · Cited by 54
Rush, C., Stoops, W. W., & Hays, L. (2008) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2008.08.009 · Cited by 57
“In summary, the results of human laboratory studies, preclinical experiments, and initial clinical trials suggest that agonist replacement therapy may be a viable strategy for the management of cocaine dependence (see Castells et al., 2007 for a review; Grabowski et al., 2001).”
BackgroundMethodReinforcing effects of stimulants in humans: Sensitivity of progressive-ratio schedules.
Stoops, W. W. (2008) · Experimental and Clinical Psychopharmacology · doi:10.1037/a0013657 · Cited by 54
“ently necessary to decrease stimulant use (Grabowski et al., 2001).”
BackgroundHaile, C. N., Mahoney, J. J., Newton, T. F., & Garza, R. D. L. (2012) · Pharmacology & Therapeutics · doi:10.1016/j.pharmthera.2012.01.010 · Cited by 56
“Accordingly, laboratory studies and outpatient clinical trials show that SR-AMPH and SR-METH reduce the subjective effects and cocaine use in dependent individuals (Grabowski et al., 2001, 2004; Mooney et al., 2009; Rush et al., 2009, 2010).”
Agonist replacement therapy for cocaine dependence: a translational review
Rush, C., & Stoops, W. W. (2012) · Future Medicinal Chemistry · doi:10.4155/fmc.11.184 · Cited by 50
“The results of the initial clinical trials suggest that amphetamine congeners are effective for treating cocaine dependence [20,97,98].”
BackgroundMethodPharmacological treatments for cocaine dependence: is there something new?
Karila, L., Reynaud, M., Aubin, H., Rolland, B., Guardia, D., Cottencin, O., & Benyamina, A. (2011) · Current pharmaceutical design · doi:10.2174/138161211796150873 · Cited by 52
“Dextro-amphetamine (15 to 60 mg/day sustained release formulation) in cocaine-dependent or in cocaine- and heroin-dependent patients showed decreased cocaine use at the higher doses (30-60 mg/day) in three double-blind, placebo-controlled studies [110, 127, 128].”
BackgroundComorbid Psychiatric and Substance Abuse Disorders: Recent Treatment Research
Riggs, P. D., Levin, F., Green, A., & Vocci, F. (2008) · Substance Abuse · doi:10.1080/08897070802218794 · Cited by 37
“However, other important questions to consider prior to starting a stimulant in a patient with a current or past history of substance abuse include: (1) Is the patient reliable? (2) Are there family members who can be involved in the treatment plan? (3) Has the patient and/or family been adequately informed of the pot…”
BackgroundCocaine choice procedures in animals, humans, and treatment-seekers: Can we bridge the divide?
Moeller, S. J., & Stoops, W. W. (2015) · Pharmacology Biochemistry and Behavior · doi:10.1016/j.pbb.2015.09.020 · Cited by 47
“, 2010) and promoted abstinence in clinical trials (Grabowski et al., 2001).”
BackgroundBanks, M. L., Hutsell, B. A., Schwienteck, K. L., & Negus, S. (2015) · Current Treatment Options in Psychiatry · doi:10.1007/s40501-015-0042-9 · Cited by 49
Levin, F., Mariani, J., Secora, A., Brooks, D. J., Cheng, W., Bisaga, A., Nunes, E., Aharonovich, E., Raby, W. N., & Hennessy, G. (2009) · Journal of dual diagnosis · doi:10.1080/15504260802628767 · Cited by 47
“Further, although stimulants may have a direct agonist effect leading to a reduction in cocaine use (Grabowski et al., 2001; Grabowski, Shearer, Merrill, & Negus, 2004), this has not been shown with atomoxetine.”
Neurobiology of the incubation of drug craving: An update
Chow, J. J., Pitts, K. M., Negishi, K., Madangopal, R., Dong, Y., Wolf, M. E., & Shaham, Y. (2024) · Pharmacological Reviews · doi:10.1016/j.pharmr.2024.100022 · Cited by 47
Mooney, M. E., Herin, D. V., Specker, S. M., Babb, D. A., LEVIN, F. R., & Grabowski, J. G. (2015) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2015.05.042 · Cited by 44
“Medication side effects were assessed via a questionnaire previously developed to capture known amphetamine side effects (Grabowski et al., 2001, 2004a; Mooney et al., 2009, 2007; Schmitz et al., 2012).”
BackgroundMethodResultInfluentialSelf-citationVerrico, C. D., Haile, C. N., Mahoney, J. J., Thompson-Lake, D. G. Y., Newton, T. F., & Garza, R. D. L. (2014) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2014.05.008 · Cited by 44
“Dextroamphetamine, which is more potent at inducing norepinephrine release than DA release (Rothman et al., 2001), significantly reduced cocaine-positive urines in two outpatient clinical trials (Grabowski et al., 2001, 2004).”
BackgroundPharmacotherapies for problematic psychostimulant use: a review of current research
Shearer, J., & Gowing, L. (2004) · Drug and Alcohol Review · doi:10.1080/09595230410001704190 · Cited by 44
Banks, M. L., Hutsell, B. A., Blough, B., Poklis, J. L., & Negus, S. (2015) · International Journal of Neuropsychopharmacology · doi:10.1093/ijnp/pyv009 · Cited by 35
“…choice by chronic d-amphetamine treatment in monkeys are consistent with clinical effectiveness of amphetamine maintenance to reduce cocaine use (Grabowski et al., 2001; Mariani et al., 2012), these results suggest that lisdexamfetamine may also be clinically effective to reduce cocaine use.”
BackgroundDopamine/serotonin releasers as medications for stimulant addictions.
Rothman, R., Blough, B., & Baumann, M. (2008) · Progress in Brain Research · doi:10.1016/s0079-6123(08)00919-9 · Cited by 43
Banks, M. L., Blough, B., Fennell, T., Snyder, R. W., & Negus, S. (2013) · Neuropsychopharmacology · doi:10.1038/npp.2013.180 · Cited by 44
Appetite Suppressants as Agonist Substitution Therapies for Stimulant Dependence
Rothman, R. B., Blough, B. E., & Baumann, M. H. (2002) · Annals of the New York Academy of Sciences · doi:10.1111/j.1749-6632.2002.tb04155.x · Cited by 41
Czoty, P., Martelle, J. L., & Nader, M. (2010) · Psychopharmacology · doi:10.1007/s00213-010-1807-x · Cited by 45
“…in patients, these data parallel clinical findings indicating a lack of serious adverse sideeffects, and only mild side-effects in a limited number of patients, associated with chronic d-amphetamine treatment (Charnaud and Griffiths 1998; Shearer et al. 2001, 2003; Grabowski et al. 2001, 2004b).”
Czoty, P. W., & Nader, M. A. (2012) · Journal of Pharmacology and Experimental Therapeutics · doi:10.1124/jpet.112.201012 · Cited by 41
Lile, J., Johnson, A. R., Banks, M. L., Hatton, K. W., Hays, L., Nicholson, K., Poklis, J. L., Rayapati, A. O., Rush, C., Stoops, W. W., et al. (2019) · Experimental and clinical psychopharmacology · doi:10.1037/pha0000302 · Cited by 33
“In addition, several clinical trials have demonstrated that maintenance on up to 60 mg/day d-amphetamine is safe and well tolerated in patients seeking treatment for their cocaine use (Grabowski et al, 2001; Schmitz et al, 2012; Shearer et al, 2003).”
BackgroundResultDrug addictions: towards socially accepted and medically treatable diseases
Pouletty, P. (2002) · Nature Reviews Drug Discovery · doi:10.1038/nrd896 · Cited by 40
Lile, J. A., Morgan, D., Birmingham, A. M., Wang, Z., Woolverton, W. L., Davies, H. M. L., & Nader, M. A. (2002) · Journal of Pharmacology and Experimental Therapeutics · doi:10.1124/jpet.102.039180 · Cited by 40
“The DA system has therefore been targeted for therapeutic development in the treatment of psychostimulant abuse, and drugs that bind to dopamine transporters (DATs) are being tested as possible agonist substitution therapies (Grabowski et al., 2001).”
BackgroundBanks, M. L., Blough, B., & Negus, S. (2013) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2013.05.005 · Cited by 42
“Moreover, the efficacy of d-amphetamine to decrease cocaine self-administration in these preclinical and human laboratory studies has been consistent with results from clinical trials (Grabowski et al., 2001; Mariani et al., 2012; Schmitz et al., 2012).”
Behavioral evaluation of modafinil and the abuse-related effects of cocaine in rhesus monkeys.
Newman, J. L., Negus, S. S., Lozama, A., Prisinzano, T. E., & Mello, N. K. (2010) · Experimental and Clinical Psychopharmacology · doi:10.1037/a0021042 · Cited by 39
“For example, putative medications such as amphetamine reduced cocaine use (Grabowski et al., 2001; Shearer, Wodak, van Beek, Mattick, & Lewis, 2003).”
Drugs currently in Phase II clinical trials for cocaine addiction
Kim, J. H., & Lawrence, A. J. (2014) · Expert Opinion on Investigational Drugs · doi:10.1517/13543784.2014.915312 · Cited by 40
Banks, M. L., & Negus, S. S. (2009) · Neuropsychopharmacology · doi:10.1038/npp.2009.154 · Cited by 40
“This finding may be partly responsible for the relatively low rates of retention in some recent clinical trials with otherwise effective agonist-based medications for cocaine dependence (Grabowski et al, 2001, 2004; Mooney et al, 2009).”
Mooney, M. E., Schmitz, J. M., Moeller, F., & Grabowski, J. (2007) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2006.10.011 · Cited by 34
“Recently, promising findings have been found for dextroamphetamine (Grabowski et al., 2001; Grabowski et al., 2004a; Shearer et al., 2003), a drug that, along with other effects, promotes release of dopamine.”
BackgroundSelf-citation
Metadata
- Authors
- Grabowski, J., Rhoades, H., Schmitz, J., Stotts, A., Daruzska, L. A., Creson, D., & Moeller, F. G.
- Venue
- Journal of Clinical Psychopharmacology
- Published
- 2001-10
- Volume
- 21
- Issue
- 5
- Pages
- 522-526
- ISSN
- 0271-0749 (ISSN-L)
- OpenAlex
- W2052304909
- Cited by
- 243
- References
- 22
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 10 · 2023: 7 · 2022: 5 · 2021: 12 · 2020: 10 · 2019: 8 · 2018: 9 · 2017: 6 · 2016: 14 · 2015: 13 · 2014: 12 · 2013: 11 · 2012: 13
- FWCI
- 7.78
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Psychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (5p50da009262-20)
- National Institute on Drug Abuse (DA RO1-6143, DA P50-9262)
- Topics
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Opioid Use Disorder Treatment
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Keywords
- d-amphetamine, cocaine dependence, treatment retention, illicit drug use, dose escalation, urine drug testing, benzoylecgonine, stimulant use disorder, behavior therapy
- MeSH terms
- Adult, Central Nervous System Stimulants, Behavior Therapy, Cocaine, Delayed-Action Preparations, Dextroamphetamine, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Patient Compliance, Patient Dropouts, Severity of Illness Index, Substance Abuse Detection, Cocaine-Related Disorders
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