Pilot Study of Varenicline to Treat Opioid Dependence

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this proposal is to explore the potential of varenicline as a pharmacotherapeutic agent for opioid dependence and addiction.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Analgesics, Opioid; Varenicline

Criteria

Inclusion criteria

• Age>=21 years

• Use of opioids at admission to PRC, with daily morphine equivalent dose>=60mg

• Be able and willing to participate fully in all aspects of the study including one month follow-up after completion of PRC

• Ability to provide informed consent

Exclusion criteria

• Currently using varenicline or other pharmacotherapy for nicotine dependence

• Currently pregnant, lactating, or likely to become pregnant during the trial and not willing to use an acceptable form of contraception;

• History of a major cardiovascular event in the past 6 months including unstable angina, acute myocardial infarction, stroke, or coronary angioplasty;

• Known varenicline allergy

• Use of any medication (e.g., methadone, Suboxone) as maintenance therapy for opiate addiction

• Identification of illicit drugs (e.g., marijuana, cocaine) on the baseline urine toxicology screen