Randomized clinical trial of disulfiram for cocaine dependence or abuse during buprenorphine treatment
Abstract
Background Disulfiram may be efficacious for treating cocaine dependence or abuse, possibly through inhibiting dopamine β-hydroxylase (DβH). Consequently, this randomized, placebo-controlled clinical trial of disulfiram during buprenorphine maintenance treatment evaluated the study hypothesis that disulfiram is superior to placebo and explored whether disulfiram response is greatest for participants with a single nucleotide polymorphism coding for genetically low DβH (T-allele carriers). Methods We randomized 177 buprenorphine-treated opioid dependent participants with cocaine dependence or abuse to 12 weeks of double-blind treatment with disulfiram 250mg daily (n=91) or placebo (n=86). Of 155 participants genotyped, 84 were CC-homozygous, and 71 CT or TT genotypes. Primary outcomes included days per week cocaine use, number of cocaine-negative urine tests, and maximum consecutive weeks of cocaine abstinence. We analyzed an intention-to-treat comparison between disulfiram and placebo. We also explored potential pharmacogenetic interactions and examined treatment responses of four participant groups based on medication (disulfiram or placebo) by genotype (CC-homozygous or T-allele carrier) classification. Results Disulfiram participants reported significantly less frequent cocaine use; the differences in cocaine-negative urine tests or consecutive weeks abstinence were not significant. Frequency of cocaine use was lowest in disulfiram-treated T-allele carriers; differences in cocaine-negative urine tests or consecutive weeks abstinence were not significant among the four medication-genotype groups. Conclusions The findings provide limited support for the efficacy of disulfiram for reducing cocaine use and suggest that its mechanism of action may involve inhibition of DβH. Further studies of its efficacy, mechanism of action, and pharmacogenetics of response are warranted.
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The findings of clinical trials (NCT00729300, NCT00149630, NCT00913484) provide limited support for the efficacy of disulfiram for reducing cocaine dependence.
“the findings of clinical trials (NCT00729300, NCT00149630, NCT00913484) provide limited support for the efficacy of DIS for reducing cocaine dependence.35,36,37”
From Off-label and repurposed use of disulfiram beyond alcohol dependence: A systematic review of clinical and preclinical evidence (2026) · cites this paper as [37]
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- Authors
- Schottenfeld, R. S., Chawarski, M. C., Cubells, J. F., George, T. P., Lappalainen, J., & Kosten, T. R.
- Affiliations
- Yale University (US)
- Emory University (US)
- University of Toronto (CA)
- Michael E. DeBakey VA Medical Center (US)
- Corresponding author
- Schottenfeld, Richard S.
- Venue
- Drug and Alcohol Dependence
- Publisher
- Elsevier BV
- Published
- 2014-03
- Volume
- 136
- Pages
- 36-42
- ISSN
- 0376-8716 (ISSN-L)
- OpenAlex
- W2035657713
- Cited by
- 31
- References
- 57
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 2 · 2022: 2 · 2021: 3 · 2020: 3 · 2019: 4 · 2018: 1 · 2016: 3 · 2015: 6 · 2014: 2
- FWCI
- 2.68
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Drug and Alcohol Dependence (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute on Drug Abuse (K24DA000445, K05DA0454, K05DA000454, K02DA015766, K02DA016611)
- 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
- disulfiram, cocaine dependence, cocaine abuse, buprenorphine maintenance treatment, opioid use disorder, dopamine beta-hydroxylase inhibition, pharmacogenetics, single nucleotide polymorphisms, cocaine abstinence
- MeSH terms
- Adolescent, Adult, Alcohol Deterrents, Alcoholism, Alleles, Buprenorphine, Data Interpretation, Statistical, Disulfiram, DNA, Double-Blind Method, Drug Therapy, Combination, Female, Genotype, Humans, Male, Middle Aged, Narcotic Antagonists, Opioid-Related Disorders, Pharmacogenetics, Polymerase Chain Reaction, Treatment Outcome, Sample Size, Cocaine-Related Disorders, Young Adult
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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