Status:
COMPLETED
Pilot Study of Varenicline to Treat Opioid Dependence
Lead Sponsor:
Mayo Clinic
Conditions:
Chronic Pain
Opioid Dependence
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
The objective of this proposal is to explore the potential of varenicline as a pharmacotherapeutic agent for opioid dependence and addiction.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01436474
Start Date
June 1 2011
End Date
December 1 2012
Last Update
January 23 2013
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905