New Medication Treatment for Stimulant Dependence

University of Virginia

Status and phase: Completed; Phase 2

Conditions: Cocaine Dependence

Treatments: Drug: Ondansetron; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00689572

1R01DA021776-01A1 (U.S. NIH Grant/Contract)

13419

Details and patient eligibility

About

This study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence.

Full description

We propose to conduct a 9 week randomized, controlled clinical trial to evaluate the efficacy of ondansetron 4 mg twice daily compared with placebo (total N = 100/group × 2 groups = 200 individuals randomized, 400 total subjects will be consented), provided as an adjunct to manual-driven, structured CBT + BBCET in the treatment of cocaine dependence.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females who have given written informed consent.
• Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg.
• Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters.
• Current DSM-IV diagnosis of cocaine dependence.
• At least one positive urine drug screen for cocaine at screen or baseline prior to randomization.
• The pregnancy test for females at intake must be negative.
• Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments.
• Answered an advertisement in the newspaper/radio/television, and expressing a wish to stop using cocaine.
• Willing to participate in behavioral treatments for cocaine dependence.

Exclusion criteria

Please contact site for additional information

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

108 participants in 2 patient groups, including a placebo group

Ondansetron

Experimental group

Description:

Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Treatment:

Drug: Ondansetron

Placebo

Placebo Comparator group

Description:

Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Treatment:

Drug: Placebo