New Medication Treatment for Stimulant Dependence

NCT00689572 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 134191R01DA021776-01A1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cocaine Dependence

Keywords

cocaine dependence; cocaine abuse; cocaine; crack

Outcome Measures

Primary Outcomes (2)

• Cocaine Use by Self-report

  Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report

  up to 9 weeks

• Cocaine Use by Urine Benzoylecgonine

  Urine samples were collected up to three times weekly for up to 9 weeks to test for the major cocaine metabolite benzoylecgonine

  up to 9 weeks

Study Arms (2)

Ondansetron

EXPERIMENTAL

Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Drug: Ondansetron

Placebo

PLACEBO COMPARATOR

Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Drug: Placebo

Interventions

Ondansetron DRUG

4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Also known as: Zofran

Ondansetron

Placebo DRUG

twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Please contact site for additional information

Sponsors & Collaborators

• University of Virginia: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of Virginia Center for Addiction Research and Education

Charlottesville, Virginia, 22911, United States

Location

University of Virginia Center for Addiction Research and Education

Richmond, Virginia, 23294, United States

Location

Related Publications (1)

• Blevins D, Seneviratne C, Wang XQ, Johnson BA, Ait-Daoud N. A randomized, double-blind, placebo-controlled trial of ondansetron for the treatment of cocaine use disorder with post hoc pharmacogenetic analysis. Drug Alcohol Depend. 2021 Nov 1;228:109074. doi: 10.1016/j.drugalcdep.2021.109074. Epub 2021 Sep 24.

  PMID: 34600264 DERIVED

Related Links

• (UVA CARE Website)

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Ondansetron; Sugars

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Carbohydrates

Results Point of Contact

• Title: Nassima Ait-Daoud Tiouririne, M.D.
• Organization: University of Virginia

nat7b@virginia.edu

(434)243-0570

Study Officials

• Nassima Ait-Daoud Tiouririne, M.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director of UVA Center for Addiction Research and Education

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 3, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 11, 2021
• Results First Posted: November 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)