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New Medication Treatment for Stimulant Dependence

Information source: University of Virginia
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine Dependence

Intervention: Ondansetron (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Virginia

Official(s) and/or principal investigator(s):
Nassima Ait-Daoud Tiouririne, M.D., Principal Investigator, Affiliation: University of Virginia

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

Summary

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

Clinical Details

Official title: New Medication Treatment for Stimulant Dependence

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: 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.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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:

- 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

- Any Axis 1 disorder that warrants treatment or would preclude safe participation in

the protocol.

- 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

- HIV with CD4 positive T cell counts <500 mm3

- Any subjects on any pharmacotherapy for the treatment of AIDS or HIV will be

excluded.

- 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 randomization) regular use of psychotropics

including, but not limited to, antidepressants, anxiolytics, anti-psychotics, anticonvulsants, and psychomotor stimulant-type medications, 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.

Locations and Contacts

Mindy Borszich, BA, Phone: 1-888-882-2345, Email: uvacare@virginia.edu

Uva Care, Charlottesville, Virginia 22911, United States; Recruiting
Nassima Ait-Daoud Tiouririne, M.D., Principal Investigator
Bankole Johnson, DSc,MD,PhD, Sub-Investigator

UVA CARE Richmond, Richmond, Virginia 23294, United States; Recruiting
Nassima Ait-Daoud Tiouririne, M.D., Principal Investigator
Bankole Johnson, DSc,MD,PhD, Sub-Investigator

Additional Information

Starting date: July 2008
Last updated: May 26, 2011

Page last updated: December 08, 2011

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