Official Title: “New Medication Treatment for Stimulant Dependence”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2012

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.

Intervention(s) in this Clinical Trial

• Drug: Ondansetron
  • 4 mg twice a day
• Drug: Placebo
  • twice a day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Ondansetron 4 mg twice a day
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Ondansetron will be superior to placebo at increasing the weekly proportion of cocaine free days.Ondansetron will be superior to placebo at increasing the weekly mean proportion of subjects with cocaine-free urines.
  • Time Frame: Throughout the study
    Safety Issue?: No

Secondary Measures

• Ondansetron will be superior to placebo at decreasing cocaine craving,and these reductions in cocaine craving will be associated with decreased cocaine intake.Ondansetron will be associated with an improvement in psychosocial functioning.
  • Time Frame: Throughout the study
    Safety Issue?: No

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 within the two-week baseline period prior to randomization with a minimum of four samples tested.
• 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:

• Current dependence, defined by DSM-IV criteria, on any psychoactive substance other than cocaine, alcohol, nicotine, caffeine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
• Neurological or psychiatric disorders
• Serious medical illnesses
• Mandated by the court to obtain treatment for cocaine dependence.
• Anyone who, in the opinion of the investigator, would not be expected to complete the study protocol because of probable incarceration or relocation from the clinic area.
• AIDS or CD4 positive T cell counts <500 mm3
• Active syphilis that has not been treated, or refused treatment for syphilis
• Severe or life-threatening adverse reactions to medications (including ondansetron) in the past or during this clinical trial.
• Currently on active treatment with ondansetron.
• Receipt of a drug with known potential for toxicity to a major organ system within 30 days prior to study entry (e.g., isoniazid, methotrexate).
• Female subjects who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study.
• Concurrent (within two weeks of study participation) pharmacotherapy with psychotropics including, but not limited to, antidepressants, anxiolytics, anti-psychotics, anticonvulsants, and psychomotor stimulant-type medications.
• Use in the last two weeks of St. John's Wort, yohimbine, ginkgo biloba, horehound, or any other central nervous system active herbal preparations.
• Use of any opiate substitutes (methadone, LAAM, buprenorphine) within 1 month preceding screening.
• Clinically significant hematological or biochemical test results that in the view of the study physician require immediate or urgent treatment.
• Pyrexia of unknown origin or neuroleptic malignant syndrome.
• Serious medical co-morbidity requiring medical intervention or close supervision, or any condition that can interfere with the receipt of ondansetron.
• Received inpatient or outpatient treatment for cocaine dependence within the last 4 weeks, or previously participated in a clinical trial utilizing ondansetron.
• Electroconvulsive therapy within the 3 months preceding screening.
• Members of the same household.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Virginia

Overall Clinical Trial Officials and Contacts

Nassima Ait-Daoud Tiouririne, M.D. Principal Investigator University of Virginia  

Overall Contact: Mindy Borszich, BA 1-888-882-2345 uvacare@virginia.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00689572

Study ID Number: 13419

ClinicalTrials.gov Identifier: NCT00689572

Health Authority: United States: Food and Drug Administration