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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA013441 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This 18-week, randomized, double blind clinical trial provided treatment for 160 cocaine-dependent opioid addicts, aged 18-65 years. Participants were stabilized on LAAM maintenance during the first 4 weeks and cocaine use was assessed; participants were then stratified by level of cocaine use and randomly assigned to receive one of the following: placebo disulfiram (0 mg/day), disulfiram at 62.5 mg/day, disulfiram at 125 mg/day, or disulfiram at 250 mg/day. During induction onto LAAM, participants were administered increasing doses of LAAM plus placebo disulfiram on a thrice-weekly basis until maintenance doses of LAAM are attained. At the beginning of week 5, participants received LAAM plus disulfiram or placebo disulfiram according to their randomized assignments, and were maintained on these agents through week 16. At the end of the study, participants underwent detoxification from LAAM and active/placebo medication over a 4- to 6-week period. All participants received weekly 1-hour psychotherapy (Cognitive Behavioral Treatment) with experienced clinicians specifically trained to deliver the therapy and who received ongoing supervision. The primary outcomes were retention and reduction in opioid and cocaine use, as assessed by self-report and confirmed by thrice-weekly urinalyses. Secondary outcomes included reductions in other illicit drug and alcohol use, as well as improvements in psychosocial functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo disulfiram | Placebo Comparator | placebo disulfiram (0 mg/day) |
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| disulfiram 62.5 | Experimental | disulfiram at 62.5 mg/day |
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| disulfiram 125 | Experimental | disulfiram at 125 mg/day |
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| disulfiram 250 | Experimental | disulfiram at 250 mg/day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matched placebo. |
| |
| Disulfiram |
| Measure | Description | Time Frame |
|---|---|---|
| Reductions in cocaine use as measured by urine toxicology and self-report | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Predictors of treatment efficacy using DBH genotyping for disulfiram will be tested. | 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Poling, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Haven VA | West Haven | Connecticut | 06516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38180268 | Derived | Traccis F, Minozzi S, Trogu E, Vacca R, Vecchi S, Pani PP, Agabio R. Disulfiram for the treatment of cocaine dependence. Cochrane Database Syst Rev. 2024 Jan 5;1(1):CD007024. doi: 10.1002/14651858.CD007024.pub3. |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
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| ID | Term |
|---|---|
| D004221 | Disulfiram |
| ID | Term |
|---|---|
| D004050 | Ditiocarb |
| D013859 | Thiocarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
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| Drug |
disulfiram at 62.5 mg/day for 12 weeks. |
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| Disulfiram | Drug | Disulfiram at 125 mg/day for 12 weeks. |
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| Disulfiram | Drug | disulfiram at 250 mg/day for 12 weeks. |
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D004220 | Disulfides |
| D013440 | Sulfides |
| D013457 | Sulfur Compounds |