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Efficacy of Varenicline in Methadone-Stabilized Cocaine Users

Primary Purpose

Cocaine Dependence, Nicotine Dependence

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Varenicline

Sugar pill or Placebo

About this trial

This is an interventional health services research trial for Cocaine Dependence focused on measuring varenicline

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Veterans Hopsital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Varenicline

Sugar Pill or Placebo

Arm Description

Placebo is compared to active drug varenicline

Outcomes

Primary Outcome Measures

Proportion of Cocaine Positive Urine Tests Per Week

Urine samples were obtained thrice-weekly and analyzed for the presence of cocaine metabolites. Levels that exceeded 300 ng / ml on each individual urine test were considered positive. The primary outcome measure was the proportions of positive cocaine urine results per week that was calculated by using the total number of completed tests as the denominator and the total number of positive tests for that week as the numerator. This data was subjected to Hierarchical Linear Modeling (HLM) analysis using a total of 13 longitudinal results that included a baseline result (Week 0).

Secondary Outcome Measures

Full Information

NCT ID

NCT00567320

First Posted

December 3, 2007

Last Updated

March 31, 2020

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA), US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT00567320

Brief Title

Efficacy of Varenicline in Methadone-Stabilized Cocaine Users

Official Title

Efficacy of Varenicline in Methadone-Stabilized Cocaine Users

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA), US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. To determine the safety and tolerability of varenicline in cocaine-using methadone-stabilized subjects. To determine if varenicline is efficacious in reducing cocaine-use in methadone-stabilized subjects.

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 Hierarchical Linear Modeling (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 suspended due to these new concerns, Department of Veterans Affairs and the P.I. James Poling agreed. Study has been published. (April 2011)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Dependence, Nicotine Dependence

Keywords

varenicline

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Varenicline

Arm Type

Active Comparator

Arm Title

Sugar Pill or Placebo

Arm Type

Active Comparator

Arm Description

Placebo is compared to active drug varenicline

Intervention Type

Drug

Intervention Name(s)

Varenicline

Other Intervention Name(s)

Chantix

Intervention Description

Varenicline up to 2 mg a day

Intervention Type

Drug

Intervention Name(s)

Sugar pill or Placebo

Other Intervention Name(s)

Sugar pill

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Proportion of Cocaine Positive Urine Tests Per Week

Description

Time Frame

Weekly Measures over 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Poling, Ph.D.

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Veterans Hopsital

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20716302

Citation

Poling J, Rounsaville B, Gonsai K, Severino K, Sofuoglu M. The safety and efficacy of varenicline in cocaine using smokers maintained on methadone: a pilot study. Am J Addict. 2010 Sep-Oct;19(5):401-8. doi: 10.1111/j.1521-0391.2010.00066.x.

Results Reference

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Efficacy of Varenicline in Methadone-Stabilized Cocaine Users

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