New Medication Treatment for Stimulant Dependence - Full Text View

Sponsor:	University of Virginia
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):	Nassima Ait-Daoud Tiouririne, University of Virginia
ClinicalTrials.gov Identifier:	NCT00689572

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 II

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:

Drug Information available for: Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

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:	January 2014
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ondansetron	Drug: Ondansetron 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy Other Name: Zofran
Placebo Comparator: Placebo	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

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Nassima Ait-Daoud Tiouririne, M.D.

University of Virginia

More 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:	February 6, 2012
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 February 09, 2012