Efficacy of Varenicline in Methadone-Stabilized Cocaine Users

NCT00567320 | Completed Results DMC

• 4 other identifiers: 0702002337R01DA021264DPMCMIRECC 000000000
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

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

Conditions

Cocaine Dependence; Nicotine Dependence

Keywords

varenicline

Outcome Measures

Primary Outcomes (1)

• 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).

  Weekly Measures over 12 weeks

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

Drug: Varenicline

Sugar Pill or Placebo

ACTIVE COMPARATOR

Placebo is compared to active drug varenicline

Drug: Sugar pill or Placebo

Interventions

Varenicline DRUG

Varenicline up to 2 mg a day

Also known as: Chantix

Varenicline

Sugar pill or Placebo DRUG

Placebo

Also known as: Sugar pill

Sugar Pill or Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Veterans Hopsital

West Haven, Connecticut, 06516, United States

Location

Related Publications (2)

• 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.

  PMID: 20716302 RESULT

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders; Tobacco Use Disorder

Interventions

Varenicline; Sugars

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Carbohydrates

Results Point of Contact

• Title: Mehmet Sofuoglu, M.D., Ph.D.
• Organization: Yale University

mehmet.sofuoglu@yale.edu

203-937-4809

Study Officials

• James Poling, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 4, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 2, 2020
• Results First Posted: April 9, 2012

Record last verified: 2013-01

Locations

US (1)