Pilot Study of Varenicline to Treat Opioid Dependence

Completed · Phase 1 · Has a placebo group

Conditions studied: Chronic Pain, Opioid Dependence

In brief

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

Key facts

Study ID

NCT01436474

Run by

Mayo Clinic

People needed

21

Starts

2011-06-01

Expected to finish

2012-12-01

Last updated by the study team

2013-01-23

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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