New Medication Treatment for Stimulant Dependence

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nassima Ait-Daoud Tiouririne, University of Virginia
ClinicalTrials.gov Identifier:
NCT00689572
First received: May 29, 2008
Last updated: June 2, 2014
Last verified: June 2014
  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: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689572

Locations
United States, Virginia
University of Virginia Center for Addiction Research and Education
Charlottesville, Virginia, United States, 22911
University of Virginia Center for Addiction Research and Education
Richmond, Virginia, United States, 23294
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: June 2, 2014
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
Chemically-Induced Disorders
Mental Disorders
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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 October 19, 2014