Efficacy of Varenicline in Methadone-Stabilized Cocaine Users
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: An Effective Pharmacotherapy for Cocaine Use Disorders
Intervention: Varenicline (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
James Poling, Ph.D., Principal Investigator, Affiliation: Yale University
Overall contact:
Joanna Vincent, BA, Phone: 203-937-4822, Email: Joanna.Vincent@yale.edu
Summary
Cocaine addiction continues to be an important public health problem in the US with a
significant cost to the individual and society. Among substance abusers, cocaine use has been
recognized as a significant problem especially in methadone-maintenance patients. In several
studies, rates of cocaine use have been reported to range from 30 to over 60 percent of those
in methadone maintenance programs (Condelli et al. 1991; Hunt et al. 1984; Kidorf and Stitzer
1993; Kosten et al. 1988). In these patients, cocaine use seems to be a predictor of poor
clinical outcome (Hartel et al. 1995; Kosten et al. 1987a). The development of effective
pharmacotherapies for cocaine use disorders, especially in the opioid-dependent population is
of great importance. Unfortunately, such effective pharmacotherapies do not exist.
1. To determine the safety and tolerability of varenicline in cocaine-using
methadone-stabilized subjects.
2. To determine if varenicline is efficacious in reducing cocaine-use in
methadone-stabilized subjects.
Clinical Details
Official title: Efficacy of Varenicline in Methadone-Stabilized Cocaine Users
Study design: Health Services Research, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment
Primary outcome: We hypothesize that varenicline treatment will decrease cocaine use in methadone-stabilized cocaine users.
Detailed description:
For this pilot study, we hope to recruit a total of 40 subjects, with 20 subjects in the
varenicline group, and 20 into the placebo-control group. Assuming significant findings,
these data will enable us to estimate a possible effect size for carrying-out a larger study.
For preliminary analysis as a prelude to planning larger controlled studies, we will
clinically require an effect size of 20% differences in the rates of cocaine positive urines
or of self-reported cocaine use between the active medication and placebo groups. We will not
adjust for these multiple comparisons to the placebo group since this is a pilot study, and
use two-tailed significance level of 0. 05 when we employ repeated measures analysis of
variance (ANOVA) or HLM (see below) for statistical analysis over the 16-week study period.
An Amendment was made and a new Updated consent form to include new FDA findings for study
medication Varenicline." Varenicline may also cause changes in behavior, agitation, depressed
mood, suicidal ideation and suicidal behavior." Currently we have 30 subjects who have
completed this study. This study is on going.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- · Males and females between 18 and 55 years old will be eligible for this study.
Females must not be pregnant as determined by pregnancy screening, nor breast feeding,
and must be using acceptable birth control methods during study participation.
- Current opioid dependence as evidenced by documentation of prior treatment for
opioid dependence or signs of withdrawal, self-reported history of opioid
dependence for consecutive 12 month period and a positive urine for opiates.
- Subjects must fulfill DSM-IV criteria for opioid dependence.
- Subjects must have a history of cocaine use, with a reported street cocaine use
of a minimum of 1/2 gram during the preceding 30 days.
- Subjects must meet DSM-IV criteria for cocaine dependence or abuse, and have
laboratory confirmation of recent cocaine use (positive urine for cocaine) during
the month prior to study entry.
- Subjects must be treatment-seekers for opioid and cocaine use.
- Subjects must have smoked at least 10 cigarette per day for at least one year.
Varenicline's safety has only been studied in smokers.
Exclusion Criteria:
- · History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest
pain, arrhythmia, hypertension.
- History of severe renal or hepatic diseases.
- History of psychosis, schizophrenia, bipolar or major depressive disorder.
- History of seizure disorder.
- Current diagnosis of alcohol, benzodiazepine and other drug abuse or dependence
(other than opiates, cocaine, and nicotine).
- Current use of over-the-counter or prescription psychoactive drugs
(antidepressant, anxiolytics, antipsychotics, mood stabilizers,
psychostimulants).
- Liver function tests (ALT or AST) greater than 3 times normal.
- Known allergy to varenicline or methadone.
Locations and Contacts
Joanna Vincent, BA, Phone: 203-937-4822, Email: Joanna.Vincent@yale.edu
Veterans Hopsital, West Haven, Connecticut 06516, United States; Recruiting
James Poling, Ph.D., Phone: 203-937-4830, Email: James.Poling@yale.edu
Mehmet Sofuoglu, M.D., Ph.D., Phone: 203-937-4809, Email: mehmet.sofuoglu@yale.edu
James Poling, Ph.D., Principal Investigator
Additional Information
Starting date: March 2007
Ending date: March 2009
Last updated: July 10, 2008
|
