New Medication Treatment for Stimulant Dependence
This study is currently recruiting participants.
Verified March 2013 by University of Virginia
Sponsor:
University of Virginia
Collaborator:
Information provided by (Responsible Party):
Nassima Ait-Daoud Tiouririne, University of Virginia
ClinicalTrials.gov Identifier:
NCT00689572
First received: May 29, 2008
Last updated: March 7, 2013
Last verified: March 2013
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Purpose
This study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Dependence |
Drug: Ondansetron Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | New Medication Treatment for Stimulant Dependence |
Resource links provided by NLM:
Further study details as provided by University of Virginia:
Primary Outcome Measures:
- increase in cocaine free days (abstinent)assessed by self-reported use and urine analysis for benzoylecgonine [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]Cocaine timeline follow-back, QFI, substance use inventory, urine benzoylecgonine
Secondary Outcome Measures:
- Decrease cocaine craving,and improvement in general well-being, social function, quality of life. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]increased scores in the following assessments: BSCS, CCQ-NOW, CGI, BSI, SFQ, Q-LES-Q, medication compliance (pill count)
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ondansetron
Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
|
Drug: Ondansetron
4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Other Name: Zofran
|
|
Placebo Comparator: Placebo
Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
|
Drug: Placebo
twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Other Name: Sugar Pill
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689572
Contacts
| Contact: Mindy Borszich | 1-888-882-2345 | mcb3x@virginia.edu |
| Contact: Eva Jenkins-Mendoza | (434)243-0562 | emj9c@virginia.edu |
Locations
| United States, Virginia | |
| University of Virginia Center for Addiction Research and Education | Recruiting |
| Charlottesville, Virginia, United States, 22911 | |
| Contact: Mindy Borszich 888-882-2345 mcb3x@virginia.edu | |
| Contact: Eva Jenkins-Mendoza (434)243-0562 emj9c@virginia.edu | |
| Principal Investigator: Nassima Ait-Daoud Tiouririne, M.D. | |
| Sub-Investigator: Bankole Johnson, DSc,MD,PhD | |
| University of Virginia Center for Addiction Research and Education | Recruiting |
| Richmond, Virginia, United States, 23294 | |
| Contact: Mindy Borszich 888-882-2345 mcb3x@virginia.edu | |
| Contact: Eva Jenkins-Mendoza (434)243-0562 emj9c@virginia.edu | |
| Principal Investigator: Nassima Ait-Daoud Tiouririne, M.D. | |
| Sub-Investigator: Bankole Johnson, DSc,MD,PhD | |
Sponsors and Collaborators
University of Virginia
Investigators
| Principal Investigator: | Nassima Ait-Daoud Tiouririne, M.D. | University of Virginia |
More Information
Additional Information:
No publications provided
| Responsible Party: | Nassima Ait-Daoud Tiouririne, Associate Professor, Director of UVA Center for Addiction Research and Education, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00689572 History of Changes |
| Other Study ID Numbers: | 13419, 1R01DA021776-01A1 |
| Study First Received: | May 29, 2008 |
| Last Updated: | March 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Virginia:
|
cocaine dependence cocaine abuse cocaine crack |
Additional relevant MeSH terms:
|
Cocaine-Related Disorders Substance-Related Disorders Mental Disorders Central Nervous System Stimulants Ondansetron Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Gastrointestinal Agents Antipruritics Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents |
ClinicalTrials.gov processed this record on May 19, 2013