N/A
N=31
Efficacy of Varenicline in Methadone-Stabilized Cocaine Users
Cocaine Dependence · Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00567320 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: Proportion of Cocaine Positive Urine Tests Per Week — .57; .58 Proportion of cocaine positive — p=0.84
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Varenicline (Drug); Sugar pill or Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Cocaine Positive Urine Tests Per Week |
.57; .58 | 0.84 |
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.
Eligibility 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 Diagnostic and Statistical Manual of Mental Disorders (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.
Data sourced from ClinicalTrials.gov (NCT00567320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.