Cocaine Abuse
Conditions
Keywords
disulfiram, cognitive behavioral therapy, contingency management, drug abuse therapy, educational/resource design/development
Brief summary
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).
Detailed description
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: 1. placebo 2. disulfiram 3. placebo plus incentives for cocaine abstinence and medication compliance (prize CM) 4. disulfiram plus incentives for cocaine abstinence and medication compliance
Interventions
DRUGdisulfiram
250mg per day of Disulfiram plus CBT
DRUGPlacebo
Placebo plus CBT
BEHAVIORALPlacebo plus Contingency Management
Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT
DRUGDisulfiram plus Contingency Management
250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-50 year old * cocaine dependent * willing to sign consent * willing to accept randomization to intervention
Exclusion criteria
* significant medical conditions * psychiatric disorder with current use of prescribed psychotropic medication * lifetime schizophrenia or bipolar disorder * suicidality or homicidality * unlikely to be able to complete 1 year follow up * unable to speak or read English at a third grade level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cocaine Use by Self Report | 12 weeks | 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. |
| Change in Cocaine Use by Urine Toxicology Results | 12 weeks | We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo (plus Cognitive Behavioral Therapy- CBT)
Placebo: Placebo plus CBT | 27 |
| Disulfiram Disulfiram (plus CBT)
disulfiram: 250mg per day of Disulfiram plus CBT | 28 |
| 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 | 22 |
| 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. | 22 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 21 | 17 | 15 | 14 |
Baseline characteristics
| Characteristic | Disulfiram Plus Contingency Management | Total | Placebo | Disulfiram | Placebo Plus Contingency Management |
|---|---|---|---|---|---|
| Age, Continuous | 39.3 years STANDARD_DEVIATION 6.3 | 39.3 years STANDARD_DEVIATION 7.5 | 39.6 years STANDARD_DEVIATION 8.8 | 39.8 years STANDARD_DEVIATION 7.5 | 38.5 years STANDARD_DEVIATION 7.4 |
| Race/Ethnicity, Customized African-American | 8 participants | 49 participants | 12 participants | 14 participants | 15 participants |
| Race/Ethnicity, Customized Cuacasian | 13 participants | 39 participants | 12 participants | 11 participants | 3 participants |
| Race/Ethnicity, Customized Latino | 0 participants | 7 participants | 2 participants | 3 participants | 2 participants |
| Race/Ethnicity, Customized Multiracial/Other | 1 participants | 4 participants | 1 participants | 0 participants | 2 participants |
| Sex: Female, Male Female | 7 Participants | 27 Participants | 4 Participants | 9 Participants | 7 Participants |
| Sex: Female, Male Male | 15 Participants | 72 Participants | 23 Participants | 19 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 27 | 17 / 28 | 10 / 22 | 17 / 22 |
| serious Total, serious adverse events | 10 / 27 | 10 / 28 | 7 / 22 | 7 / 22 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Cocaine Use by Self Report | 72.2 percentage of days abstinent | Standard Deviation 27.3 |
| Disulfiram | Change in Cocaine Use by Self Report | 79.2 percentage of days abstinent | Standard Deviation 18.1 |
| Placebo Plus Contingency Management | Change in Cocaine Use by Self Report | 91.1 percentage of days abstinent | Standard Deviation 13.6 |
| Disulfiram Plus Contingency Management | Change in Cocaine Use by Self Report | 69.6 percentage of days abstinent | Standard Deviation 31.7 |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Cocaine Use by Urine Toxicology Results | 17.9 percentage of negative urines | Standard Deviation 32.3 |
| Disulfiram | Change in Cocaine Use by Urine Toxicology Results | 30.1 percentage of negative urines | Standard Deviation 39.6 |
| Placebo Plus Contingency Management | Change in Cocaine Use by Urine Toxicology Results | 53 percentage of negative urines | Standard Deviation 41 |
| Disulfiram Plus Contingency Management | Change in Cocaine Use by Urine Toxicology Results | 42.6 percentage of negative urines | Standard Deviation 43.7 |