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New Medication Treatment for Stimulant Dependence

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ondansetron
Placebo
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring cocaine dependence, cocaine abuse, cocaine, crack

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Virginia Center for Addiction Research and Education
  • University of Virginia Center for Addiction Research and Education

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ondansetron

Placebo

Arm Description

Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
May 29, 2008
Last Updated
October 15, 2021
Sponsor
University of Virginia
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00689572
Brief Title
New Medication Treatment for Stimulant Dependence
Official Title
New Medication Treatment for Stimulant Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
cocaine dependence, cocaine abuse, cocaine, crack

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ondansetron
Arm Type
Experimental
Arm Description
Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Primary Outcome Measure Information:
Title
Cocaine Use by Self-report
Description
Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report
Time Frame
up to 9 weeks
Title
Cocaine Use by Urine Benzoylecgonine
Description
Urine samples were collected up to three times weekly for up to 9 weeks to test for the major cocaine metabolite benzoylecgonine
Time Frame
up to 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nassima Ait-Daoud Tiouririne, M.D.
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Center for Addiction Research and Education
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
University of Virginia Center for Addiction Research and Education
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34600264
Citation
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.
Results Reference
derived
Links:
URL
https://med.virginia.edu/uva-clear/
Description
(UVA CARE Website)

Learn more about this trial

New Medication Treatment for Stimulant Dependence

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