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. 2024 Jan 5;1(1):CD007024.
doi: 10.1002/14651858.CD007024.pub3.

Disulfiram for the treatment of cocaine dependence

Francesco Traccis #  1 , Silvia Minozzi #  2 , Emanuela Trogu  3 , Rosangela Vacca  4 , Simona Vecchi  2 , Pier Paolo Pani  5 , Roberta Agabio  1
Affiliations

Disulfiram for the treatment of cocaine dependence

Francesco Traccis et al. Cochrane Database Syst Rev. .

Abstract

Background: Cocaine is a psychostimulant used by approximately 0.4% of the general population worldwide. Cocaine dependence is a chronic mental disorder characterised by the inability to control cocaine use and a host of severe medical and psychosocial complications. There is current no approved pharmacological treatment for cocaine dependence. Some researchers have proposed disulfiram, a medication approved to treat alcohol use disorder. This is an update of a Cochrane review first published in 2010.

Objectives: To evaluate the efficacy and safety of disulfiram for the treatment of cocaine dependence.

Search methods: We updated our searches of the following databases to August 2022: the Cochrane Drugs and Alcohol Group Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and PsycINFO. We also searched for ongoing and unpublished studies via two trials registries. We handsearched the references of topic-related systematic reviews and included studies. The searches had no language restrictions.

Selection criteria: We included randomised controlled trials that evaluated disulfiram alone or associated with psychosocial interventions versus placebo, no intervention, other pharmacological interventions, or any psychosocial intervention for the treatment of cocaine dependence.

Data collection and analysis: We used standard methodological procedures expected by Cochrane.

Main results: Thirteen studies (1191 participants) met our inclusion criteria. Disulfiram versus placebo or no treatment Disulfiram compared to placebo may increase the number of people who are abstinent at the end of treatment (point abstinence; risk ratio (RR) 1.58, 95% confidence interval (CI) 1.05 to 2.36; 3 datasets, 142 participants; low-certainty evidence). However, compared to placebo or no pharmacological treatment, disulfiram may have little or no effect on frequency of cocaine use (standardised mean difference (SMD) -0.11 standard deviations (SDs), 95% CI -0.39 to 0.17; 13 datasets, 818 participants), amount of cocaine use (SMD -0.00 SDs, 95% CI -0.30 to 0.30; 7 datasets, 376 participants), continuous abstinence (RR 1.23, 95% CI 0.80 to 1.91; 6 datasets, 386 participants), and dropout for any reason (RR 1.20, 95% CI 0.92 to 1.55; 14 datasets, 841 participants). The certainty of the evidence was low for all these outcomes. We are unsure about the effects of disulfiram versus placebo on dropout due to adverse events (RR 12.97, 95% CI 0.77 to 218.37; 1 study, 67 participants) and on the occurrence of adverse events (RR 3.00, 95% CI 0.35 to 25.98), because the certainty of the evidence was very low for these outcomes. Disulfiram versus naltrexone Disulfiram compared with naltrexone may reduce the frequency of cocaine use (mean difference (MD) -1.90 days, 95% CI -3.37 to -0.43; 2 datasets, 123 participants; low-certainty evidence) and may have little or no effect on amount of cocaine use (SMD 0.12 SDs, 95% CI -0.27 to 0.51, 2 datasets, 123 participants; low-certainty evidence). We are unsure about the effect of disulfiram versus naltrexone on dropout for any reason (RR 0.86, 95% CI 0.56 to 1.32, 3 datasets, 131 participants) and dropout due to adverse events (RR 0.50, 95% CI 0.07 to 3.55; 1 dataset, 8 participants), because the certainty of the evidence was very low for these outcomes.

Authors' conclusions: Our results show that disulfiram compared to placebo may increase point abstinence. However, disulfiram compared to placebo or no pharmacological treatment may have little or no effect on frequency of cocaine use, amount of cocaine use, continued abstinence, and dropout for any reason. We are unsure if disulfiram has any adverse effects in this population. Caution is required when transferring our results to clinical practice.

Trial registration: ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT02134002 NCT00000278 NCT00580827.

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Conflict of interest statement

FT: none known SM is the Joint Co‐ordinating Editor of Cochrane Drugs and Alcohol Group. She was not involved in the editorial process of the current protocol. ET: none known RV: none known SV: none known PP: none known RA: is an Editor of Cochrane Drugs and Alcohol Group. She was not involved in the editorial process of the current protocol.

Figures

1
1
PRISMA flow diagram illustrating the study selection process.
2
2
Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each methodological quality item presented as percentages across all included studies.
4
4
Forest plot of comparison: 1 Disulfiram versus placebo or no pharmacological treatment; outcome: 1 Frequency of cocaine use (mean number of days or weeks of cocaine use at the end of treatment).
5
5
Funnel plot for comparison: 1 Disulfiram versus placebo or no pharmacological treatment; outcome: 1 Frequency of cocaine use.
6
6
Forest plot of comparison: 1 Disulfiram versus placebo or no pharmacological treatment; outcome: 2 Amount of cocaine use (mean weight of cocaine used or money spent on cocaine at the end of treatment)
7
7
Forest plot of comparison: 1 Disulfiram versus placebo or no pharmacological treatment; outcome: 3 Continuous abstinence (number of participants who had achieved and maintained abstinence for at least three weeks at the end of treatment)
8
8
Forest plot of comparison: 1 Disulfiram versus placebo or no pharmacological treatment; outcome: 4 Point abstinence (number of participants who were abstinent at the end of treatment).
9
9
Funnel plot for comparison: 1 Disulfiram versus placebo or no pharmacological treatment; outcome: 5 Dropout for any reason
1.1
1.1. Analysis
Comparison 1: Disulfiram versus placebo or no pharmacological treatment, Outcome 1: Frequency of cocaine use
1.2
1.2. Analysis
Comparison 1: Disulfiram versus placebo or no pharmacological treatment, Outcome 2: Amount of cocaine use
1.3
1.3. Analysis
Comparison 1: Disulfiram versus placebo or no pharmacological treatment, Outcome 3: Continuous abstinence
1.4
1.4. Analysis
Comparison 1: Disulfiram versus placebo or no pharmacological treatment, Outcome 4: Point abstinence
1.5
1.5. Analysis
Comparison 1: Disulfiram versus placebo or no pharmacological treatment, Outcome 5: Dropout for any reason
1.6
1.6. Analysis
Comparison 1: Disulfiram versus placebo or no pharmacological treatment, Outcome 6: Dropout due to adverse events
1.7
1.7. Analysis
Comparison 1: Disulfiram versus placebo or no pharmacological treatment, Outcome 7: Any adverse events
1.8
1.8. Analysis
Comparison 1: Disulfiram versus placebo or no pharmacological treatment, Outcome 8: Individual adverse events
1.9
1.9. Analysis
Comparison 1: Disulfiram versus placebo or no pharmacological treatment, Outcome 9: Craving (measured on a visual analogue scale of 0–100 points)
1.10
1.10. Analysis
Comparison 1: Disulfiram versus placebo or no pharmacological treatment, Outcome 10: Depression (measured on a scale of 0–52 points)
1.11
1.11. Analysis
Comparison 1: Disulfiram versus placebo or no pharmacological treatment, Outcome 11: Anxiety (measured on a scale of 0–56 points)
2.1
2.1. Analysis
Comparison 2: Disulfiram versus naltrexone, Outcome 1: Frequency of cocaine use
2.2
2.2. Analysis
Comparison 2: Disulfiram versus naltrexone, Outcome 2: Amount of cocaine use
2.3
2.3. Analysis
Comparison 2: Disulfiram versus naltrexone, Outcome 3: Dropout for any reason
2.4
2.4. Analysis
Comparison 2: Disulfiram versus naltrexone, Outcome 4: Dropout due to adverse events
2.5
2.5. Analysis
Comparison 2: Disulfiram versus naltrexone, Outcome 5: Individual adverse events
2.6
2.6. Analysis
Comparison 2: Disulfiram versus naltrexone, Outcome 6: Craving (measured on a visual analogue scale of 0–100 points)
2.7
2.7. Analysis
Comparison 2: Disulfiram versus naltrexone, Outcome 7: Depression (measured on a scale of 0–52 points)
2.8
2.8. Analysis
Comparison 2: Disulfiram versus naltrexone, Outcome 8: Anxiety (measured on a scale of 0–56 points)
3.1
3.1. Analysis
Comparison 3: Disulfiram versus placebo or no pharmacological treatment (subgroup analyses), Outcome 1: Frequency of cocaine use (according to the presence of alcohol dependence)
3.2
3.2. Analysis
Comparison 3: Disulfiram versus placebo or no pharmacological treatment (subgroup analyses), Outcome 2: Frequency of cocaine use (according to the presence of opioid dependence in opioid agonist treatment)
3.3
3.3. Analysis
Comparison 3: Disulfiram versus placebo or no pharmacological treatment (subgroup analyses), Outcome 3: Dropout for any reason (according to the presence of comorbid alcohol dependence)
3.4
3.4. Analysis
Comparison 3: Disulfiram versus placebo or no pharmacological treatment (subgroup analyses), Outcome 4: Dropout for any reason (according to the presence of opioid dependence in opioid agonist treatment)
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Baldacara 2013 {published data only}
    1. ACTRN12611000103965. Disulfiram for the treatment of crack dependence. A pilot study. anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000103965 (first received 31 January 2012).
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Carroll 1993 {published data only}
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Carroll 1998 dataset a {published data only}
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Carroll 1998 dataset b {published data only}
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Carroll 2004 dataset a {published data only}
    1. Carroll KM, Fenton LR, Ball SA, Nich CN, Frankforter TL, Shi J, et al. Efficacy of Disulfiram and cognitive behavioral therapy in cocaine-dependent outpatients. Archives of General Psychiatry 2004;61:264-72. - PMC - PubMed
Carroll 2004 dataset b {published data only}
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Carroll 2012 dataset a {published data only}
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Carroll 2012 dataset b {published data only}
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Carroll 2016 dataset a {published data only}
    1. Carroll KM, Nich C, Petry NM, Eagan DA, Shi JM, & Ball SA. A randomized factorial trial of disulfiram and contingency management to enhance cognitive behavioral therapy for cocaine dependence. Drug and Alcohol Dependence 2016;160:135-42. - PMC - PubMed
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    1. NCT00350870. CBT with disulfiram and contingency management. clinicaltrials.gov/show/NCT00350870 (first received 11 July 2006).
Carroll 2016 dataset b {published data only}
    1. Carroll KM, Nich C, Petry NM, Eagan DA, Shi JM, Ball SA. A randomized factorial trial of disulfiram and contingency management to enhance cognitive behavioral therapy for cocaine dependence. Drug and Alcohol Dependence 2016;160:135-42. - PMC - PubMed
    1. DeVito EE, Dong G, Kober H, Xu J, Carroll KM, Potenza MN. Functional neural changes following behavioral therapies and disulfiram for cocaine dependence. Psychology of Addictive Behavior 2017;31:534. - PMC - PubMed
George 2000 {published data only}
    1. George TP, Chawarski MC, Pakes J, Carroll KM, Kosten TDR, Schottenfeld RS. Disulfiram versus placebo for cocaine dependence in Buprenorhine-mantained subjects: a preliminary trial. Biological Psychiatry 2000;47:1080-6. - PubMed
Grassi 2007 dataset a {published data only}
    1. Grassi MC, Cioce AM, Giudici FD, Antonilli L, Nencini P. Short-term efficacy of disulfiram or naltrexone in reducing positive urinalysis for both cocaine and cocaethylene in cocaine abusers: a pilot study. Pharmacological Research 2007;55(2):117-21. - PubMed
Grassi 2007 dataset b {published data only}
    1. Grassi MC, Cioce AM, Giudici FD, Antonilli L, Nencini P. Short-term efficacy of disulfiram or naltrexone in reducing positive urinalysis for both cocaine and cocaethylene in cocaine abusers: a pilot study. Pharmacological Research 2007;55(2):117-21. - PubMed
Kosten 2013 {published data only}
    1. Kampangkaew JP, Spellicy CJ, Nielsen EM, Harding MJ, Ye A, Hamon SC, et al. Pharmacogenetic role of dopamine transporter (SLC6A3) variation on response to disulfiram treatment for cocaine addiction. American Journal on Addictions 2019 Jul;28(4):311-7. - PMC - PubMed
    1. Kosten TR, Wu G, Huang W, Harding MJ, Hamon SC, Lappalainen J, et al. Pharmacogenetic randomized trial for cocaine abuse: disulfiram and dopamine beta-hydroxylase. Biological Psychiatry 2013;73(3):219-24. - PMC - PubMed
    1. NCT00000278. Disulfiram for cocaine-alcohol abuse - 3. clinicaltrials.gov/show/NCT00000278 (first received 21 September 1999).
    1. NCT00149630. Pharmacogenetics of disulfiram for cocaine. clinicaltrials.gov/show/NCT00149630 (first received 8 September 2005).
    1. NCT00729300. A study of the relationship between disulfiram and cocaine self-administration. clinicaltrials.gov/show/NCT00729300 (first received 7 August 2008).
Oliveto 2011 dataset a {published data only}
    1. Atkinson TS, Sanders N, Mancino M, Oliveto A. Effects of disulfiram on QTc interval in non-opioid-dependent and methadone-treated cocaine-dependent patients. Journal of Addiction Medicine 2013;7(4):243-8. [DOI: 10.1097/ADM.0b013e3182928e02] - DOI - PMC - PubMed
    1. NCT00395850. Disulfiram for cocaine abuse. clinicaltrials.gov/show/NCT00395850 (first received 2 November 2006).
    1. NCT00580827. Clinical efficacy of disulfiram in LAAM-maintained cocaine abusers. clinicaltrials.gov/show/ NCT00580827 (first received 27 December 2007).
    1. Oliveto A, Poling J, Mancino MJ, Feldman Z, Cubells JF, Pruzinsky R, et al. Randomized, double blind, placebo-controlled trial of disulfiram for the treatment of cocaine dependence in methadone-stabilized patients. Drugs and Alcohol Dependence 2011;113(2-3):184-91. - PMC - PubMed
Oliveto 2011 dataset b {published data only}
    1. NCT00395850. Disulfiram for Cocaine Abuse. clinicaltrials.gov/show/ NCT00395850 (first received 2 November 2006). [ClinicalTrials.gov Identifier: NCT00395850.]
    1. Oliveto A, Poling J, Mancino MJ, Feldman Z, Cubells JF, Pruzinsky R, et al. Randomized, double blind, placebo-controlled trial of disulfiram for the treatment of cocaine dependence in methadone-stabilized patients. Drugs and Alcohol Dependence 2011;113(2-3):184-91. - PMC - PubMed
Oliveto 2011 dataset c {published data only}
    1. NCT00395850. Disulfiram for cocaine abuse. clinicaltrials.gov/show/ NCT00395850;(first received 2 November 2006).
    1. Oliveto A, Poling J, Mancino MJ, Feldman Z, Cubells JF, Pruzinsky R, et al. Randomized, double blind, placebo-controlled trial of disulfiram for the treatment of cocaine dependence in methadone-stabilized patients. Drugs and Alcohol Dependence 2011;113(2-3):184-91. - PMC - PubMed
Petrakis 2000 {published data only}
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Pettinati 2008 dataset a {published data only}
    1. NCT00142844. Combination of disulfiram plus naltrexone to treat both cocaine- and alcohol-dependent individuals - 1 [Two medications, disulfiram and naltrexone, in the treatment of patients with both cocaine and alcohol dependence]. clinicaltrials.gov/show/NCT00142844 (first received 2 September 2005). [Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1 - Full Text View - ClinicalTrials.gov]
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Pettinati 2008 dataset b {published data only}
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Schottenfeld 2013 {published data only}
    1. NCT00913484. Disulfiram for cocaine abuse in buprenorphine treatment. clinicaltrials.gov/show/ NCT00913484 (first received 4 June 2009).
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References to studies excluded from this review

Assistance Publique ‐ Hôpitaux de Paris 2014 {published data only}
    1. NCT02134002. A PET Exploration of the Mechanism of Action of Dopamine Beta-hydroxylase Inhibition in Cocaine Addicts (RAPID). clinicaltrials.gov/show/NCT02134002 (first received 8 May 2014).
Baker 2007 {published data only}
    1. Baker JR, Jatlow P, McCance-Katz EF. Disulfiram effects on responses to intravenous cocaine administration. Drug and Alcohol Dependence 2007;87(2-3):202-9. - PMC - PubMed
Carroll 2000 {published data only}
    1. Carroll KM, Nich C, Ball SA, McCance E, Frankforter TL, Rounsaville. One-year follow-up of disulfiram and psychotherapy for cocaine-alcohol users: sustained effects of treatment. Addiction 2000;95(9):1335-49. - PubMed
DeVito 2014 {published data only}
    1. DeVito EE, Babuscio TA, Nich C, Ball SA, Carroll KM. Gender differences in clinical outcomes for cocaine dependence: randomized clinical trials of behavioral therapy and disulfiram. Drug and Alcohol Dependence 2014;145:156-67. - PMC - PubMed
Easton 2007 {published data only}
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Haile 2012 {published data only}
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Jofre‐Bonet 2004 {published data only}
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McCance 1998a {published data only}
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References to ongoing studies

NCT00000278 {unpublished data only}
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NCT00094289 {published data only}
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NCT00580827 {unpublished data only}
    1. NCT00580827. clinical efficacy of disulfiram in LAAM-maintained cocaine abusers. clinicaltrials.gov/show/NCT00580827 (first received 27 December 2007).

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