Pilot Study of Varenicline to Treat Opioid Dependence

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Chronic Pain; Opioid Dependence

Treatments: Drug: Varenicline; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01436474

11-002062

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

21 participants in 2 patient groups, including a placebo group

Varenicline

Experimental group

Description:

We will be comparing Varenicline to placebo in a single-blinded placebo controlled, randomized study

Treatment:

Drug: Varenicline

Placebo

Placebo Comparator group

Description:

We will be using a placebo in a randomized, controlled, single-blinded trial to look at varenicline for the indication of facilitating opioid tapering in opioid-dependent patients with chronic pain.

Treatment:

Drug: Placebo