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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DA019078 | 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 is a study of four treatments for chronic cocaine use and may help study participants to control their drug use. All participants will receive weekly individual cognitive behavioral therapy (CBT).
This study will compare four types of treatment involving skills training and incentives for attending sessions or taking study medication. Disulfiram is a widely prescribed deterrent to alcohol use. In addition to weekly cognitive behavioral therapy (CBT), participants will be assigned to one of the following treatments:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (plus Cognitive Behavioral Therapy- CBT) |
|
| Disulfiram | Active Comparator | Disulfiram (plus CBT) |
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| Placebo plus Contingency Management | Placebo Comparator | Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). |
|
| Disulfiram plus Contingency Management | Active Comparator | Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| disulfiram | Drug | 250mg per day of Disulfiram plus CBT |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cocaine Use by Self Report | Self-reports of substance use will be documented at each contact via the Substance Use Calendar. Similar to the Form-90 and the Time Line Follow-Back, which have been shown to be reliable and valid instruments for monitoring substance use and other outcomes in longitudinal studies202-204, the Substance Use Calendar allows a flexible, continuous evaluation of substance use on a daily basis. | 12 weeks |
| Change in Cocaine Use by Urine Toxicology Results | We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M. Carroll, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APT Foundation | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42423707 | Derived | Schick MR, Jaramillo Y, Kiluk BD, Nich C, LaPaglia D, Haeny AM. Testing measurement invariance of the Brief Symptom Inventory across race, sex, and time among adults with cocaine use disorder. Psychol Assess. 2026 Jul 9. doi: 10.1037/pas0001486. Online ahead of print. | |
| 22775772 | Derived | Worhunsky PD, Stevens MC, Carroll KM, Rounsaville BJ, Calhoun VD, Pearlson GD, Potenza MN. Functional brain networks associated with cognitive control, cocaine dependence, and treatment outcome. Psychol Addict Behav. 2013 Jun;27(2):477-88. doi: 10.1037/a0029092. Epub 2012 Jul 9. |
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181 patients were assessed for eligibility. 40 were found to be ineligible, and 42 did not complete the screening. 99 were randomized, but only 80 started (defined as having at least 1 day of study medication).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (plus Cognitive Behavioral Therapy- CBT) Placebo: Placebo plus CBT |
| FG001 | Disulfiram | Disulfiram (plus CBT) disulfiram: 250mg per day of Disulfiram plus CBT |
| FG002 | Placebo Plus Contingency Management | Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT |
| FG003 | Disulfiram Plus Contingency Management | Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (plus Cognitive Behavioral Therapy- CBT) Placebo: Placebo plus CBT |
| BG001 | Disulfiram | Disulfiram (plus CBT) disulfiram: 250mg per day of Disulfiram plus CBT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Cocaine Use by Self Report | Self-reports of substance use will be documented at each contact via the Substance Use Calendar. Similar to the Form-90 and the Time Line Follow-Back, which have been shown to be reliable and valid instruments for monitoring substance use and other outcomes in longitudinal studies202-204, the Substance Use Calendar allows a flexible, continuous evaluation of substance use on a daily basis. | Posted | Mean | Standard Deviation | percentage of days abstinent | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo (plus Cognitive Behavioral Therapy- CBT) Placebo: Placebo plus CBT |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical Hospitilization | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen M. Carroll | Yale University School Of Medicine Department of Psychiatry | 203-937-3486 | 7403 | kathleen.carroll@yale.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004221 | Disulfiram |
| ID | Term |
|---|---|
| D004050 | Ditiocarb |
| D013859 | Thiocarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
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| Placebo | Drug | Placebo plus CBT |
|
| Placebo plus Contingency Management | Behavioral | Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT |
|
| Disulfiram plus Contingency Management | Drug | 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT. |
|
|
| 22695473 | Derived | Carroll KM, Nich C, Shi JM, Eagan D, Ball SA. Efficacy of disulfiram and Twelve Step Facilitation in cocaine-dependent individuals maintained on methadone: a randomized placebo-controlled trial. Drug Alcohol Depend. 2012 Nov 1;126(1-2):224-31. doi: 10.1016/j.drugalcdep.2012.05.019. Epub 2012 Jun 12. |
| Physician Decision |
|
| BG002 | Placebo Plus Contingency Management | Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT |
| BG003 | Disulfiram Plus Contingency Management | Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG002 | Placebo Plus Contingency Management | Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT |
| OG003 | Disulfiram Plus Contingency Management | Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT. |
|
|
| Primary | Change in Cocaine Use by Urine Toxicology Results | We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids. | Posted | Mean | Standard Deviation | percentage of negative urines | 12 weeks |
|
|
|
| 10 |
| 27 |
| 12 |
| 27 |
| EG001 | Disulfiram | Disulfiram (plus CBT) disulfiram: 250mg per day of Disulfiram plus CBT | 10 | 28 | 17 | 28 |
| EG002 | Placebo Plus Contingency Management | Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT | 7 | 22 | 10 | 22 |
| EG003 | Disulfiram Plus Contingency Management | Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT. | 7 | 22 | 17 | 22 |
| Substance Use Hospitalization | General disorders | Systematic Assessment |
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| Psychiatric Hospitalization | Psychiatric disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Restlessness | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Tremors | General disorders | Systematic Assessment |
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| Optic Neuritis | Eye disorders | Systematic Assessment |
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| Nausea and Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea/Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Aftertaste | General disorders | Systematic Assessment |
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| Peripheral Neuritis | Eye disorders | Systematic Assessment |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D004220 | Disulfides |
| D013440 | Sulfides |
| D013457 | Sulfur Compounds |