Cited by 238Substance Abuse Treatment and OutcomesNeurotransmitter Receptor Influence on BehaviorOpioid Use Disorder Treatment

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Modafinil for the treatment of cocaine dependence

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Anderson, Ann L., Reid, Malcolm S., Li, Shou-Hua, Holmes, Tyson, Shemanski, Lynn, Slee, April, Smith, Edwina V., Kahn, Roberta, Chiang, Nora, Vocci, Frank, Ciraulo, Domenic, Dackis, Charles, Roache, John D., Salloum, Ihsan M., Somoza, Eugene, Urschel, Harold C., Elkashef, Ahmed M.·2009·Drug and Alcohol Dependence

DOI 10.1016/j.drugalcdep.2009.04.015PMC PMC2818032

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Abstract

Aim Modafinil was tested for efficacy in facilitating abstinence in cocaine-dependent patients, compared to placebo.Methods This was a double-blind placebo-controlled study, with 12 weeks of treatment and a 4-week follow-up. Six outpatient substance abuse treatment clinics participated in the study. There were 210 treatment-seekers randomized, having a diagnosis of cocaine dependence; 72 participants were randomized to placebo, 69 to modafinil 200mg, and 69 to modafinil 400mg, taken once daily on awakening. Participants came to the clinic three times per week for assessments and urine drug screens, and had one hour of individual psychotherapy weekly. The primary outcome measure was the weekly percentage of cocaine non-use days.Results The GEE regression analysis showed that for the total sample, there was no significant difference between either modafinil group and placebo in the change in average weekly percent of cocaine non-use days over the 12-week treatment period (p>0.79). However, two secondary outcomes showed significant effects by modafinil 200mg: the maximum number of consecutive non-use days for cocaine (p=0.02), and a reduction in craving (p=0.04). Also, a post hoc analysis showed a significant effect of modafinil that increased the weekly percentage of non-use days in the subgroup of those cocaine patients who did not have a history of alcohol dependence (p<0.02).Conclusions These data suggest that modafinil, in combination with individual behavioral therapy, was effective for increasing cocaine non-use days in participants without co-morbid alcohol dependence, and in reducing cocaine craving.

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Background
A Double-Blind, Placebo-Controlled Trial of Modafinil for Cocaine Dependence
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Background
A double-blind, placebo-controlled trial of modafinil for cocaine dependence
Dackis, C. A., Kampman, K. M., Lynch, K. G., Plebani, J. G., Pettinati, H. M., Sparkman, T., & O'Brien, C. P. (2012) · Journal of Substance Abuse Treatment · doi:10.1016/j.jsat.2011.12.014 · Cited by 187
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“For example, modafinil is a cognitive enhancer that has been tested as a treatment option (Anderson et al. 2009; Brandt et al. 2021; Buchholz and Saxon 2019; Sangroula et al. 2017).”
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Modafinil: an anti-relapse medication
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“For instance, alcohol co-use prevents modafinil from reducing cocaine seeking (Anderson et al., 2009).”
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“The Division of Pharmacotherapies and Medical Consequences of Drug Abuse at the National Institute on Drug Abuse has employed the HRBS in various clinical trials for the treatment of cocaine or methamphetamine dependence (e.g., Anderson et al., 2009; Kahn et al., 2009).”
Self-citation
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Dackis, C. A., & O’Brien, C. P. (2010) · American Journal of Psychiatry · doi:10.1176/appi.ajp.2009.09111613 · Cited by 2
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“In another study examining the effects of modafinil in cocaine use disorder, a trend toward decreased cocaine craving was more associated with modafinil 200 mg/day compared to 400 mg/day (Anderson et al. 2009).”
Cocaine craving and use during pharmacotherapy trials for cocaine use disorder: A multi-trajectory analysis
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“…receptor agonist baclofen (Kahn et al., 2009), the dopamine D2 agonist cabergoline (Shoptow et al., 2025), the non-amphetamine stimulant modafinil (Anderson et al., 2009), the vesicular monoamine transporter blocker reserpine (Winhusen et al., 2007b), and the GABA reuptake inhibitor tiagabine…”
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Barroso, D., Kotochinsky, M., Alessi, M. R., Amador, W. F. O., Godoi, D. C., Sabloak, R., Pereira, S. I. D. S., Ansari, Y., Amorim, K. G., Barbosa, G., et al. (2026) · Substance use & addiction journal · doi:10.1177/29767342261443842
“32,33 Within this context, ato-moxetine exemplifies a recurring pattern in which agents with strong mechanistic rationale fail to translate into clinical effectiveness.”
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Medication Development for the Treatment of Cocaine Addiction – Progress at Preclinical and Clinical Levels
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“The therapeutic effects of modafinil in cocaine users have been supported by a recently completed multi-site, placebo-controlled clinical trial involving 210 cocaine-dependent outpatients (Anderson et al., 2009).”
A few words on ‘Which medications are suitable for agonist drug maintenance?’
SHOPTAW, S. J. (2016) · Addiction · doi:10.1111/add.13306 · Cited by 1
“For example, while modafinil significantly reduces cocaine use for individuals addicted to cocaine only [6], it has no effects on cocaine use in the broader group of individuals addicted to both cocaine and alcohol [7].”
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Authors: Anderson, A. L., Reid, M. S., Li, S.-H., Holmes, T., Shemanski, L., Slee, A., Smith, E. V., Kahn, R., Chiang, N., Vocci, F., Ciraulo, D., Dackis, C., Roache, J. D., Salloum, I. M., Somoza, E., Urschel, H. C., & Elkashef, A. M.
Affiliations: National Institutes of Health (US)
New York University (US)
Stanford Medicine (US)
Boston University (US)
University of Pennsylvania (US)
The University of Texas at San Antonio Health Science Center (US)
University of Miami (US)
Corresponding author: Anderson, Ann L.
ORCID: Holmes, Tyson
Slee, April
Vocci, Frank
Ciraulo, Domenic
Roache, John D.
Salloum, Ihsan M.
Elkashef, Ahmed M.
Venue: Drug and Alcohol Dependence
Publisher: Elsevier BV
Published: 2009-09
Volume: 104
Issue: 1-2
Pages: 133-139
ISSN: 0376-8716 (ISSN-L)
DOI: 10.1016/j.drugalcdep.2009.04.015
PMC: PMC2818032
OpenAlex: W2140991283
Cited by: 235
References: 27
Citations by year: 2026: 8 · 2025: 9 · 2024: 15 · 2023: 10 · 2022: 10 · 2021: 15 · 2020: 8 · 2019: 9 · 2018: 7 · 2017: 4 · 2016: 20 · 2015: 15 · 2014: 20 · 2013: 15 · 2012: 28
FWCI: 15.67
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Drug and Alcohol Dependence (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Institutes of Health (Z99 DA999999)
National Institute on Drug Abuse (N01DA-3-8838)
Topics: Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Opioid Use Disorder Treatment
Keywords: modafinil, cocaine dependence, cocaine abstinence, cocaine craving, stimulant use disorder, individual psychotherapy
MeSH terms: Modafinil, Adult, Alcoholism, Central Nervous System Stimulants, Benzhydryl Compounds, Combined Modality Therapy, Double-Blind Method, Ethnicity, Female, Humans, Male, Patient Compliance, Psychiatric Status Rating Scales, Psychotherapy, Risk Factors, Socioeconomic Factors, Urinalysis, Treatment Outcome, Cocaine-Related Disorders

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