CBT With Disulfiram and Contingency Management

Yale University

Status and phase: Completed; Phase 1

Conditions: Cocaine Abuse

Treatments: Drug: Disulfiram plus Contingency Management; Drug: Placebo; Drug: disulfiram; Behavioral: Placebo plus Contingency Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00350870

5R01DA019078 (U.S. NIH Grant/Contract)

0408026992

Details and patient eligibility

About

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).

Full 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

Enrollment: 181 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

181 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo (plus Cognitive Behavioral Therapy- CBT)

Treatment:

Drug: Placebo

Disulfiram

Active Comparator group

Description:

Disulfiram (plus CBT)

Treatment:

Drug: disulfiram

Placebo plus Contingency Management

Placebo Comparator group

Description:

Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).

Treatment:

Behavioral: Placebo plus Contingency Management

Disulfiram plus Contingency Management

Active Comparator group

Description:

Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).

Treatment:

Drug: Disulfiram plus Contingency Management