Pilot Study of Varenicline to Treat Opioid Dependence

NCT ID: NCT01436474

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-12-31

Brief Summary

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

Conditions

Chronic Pain; Opioid Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Varenicline

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

Group Type: EXPERIMENTAL

Varenicline

Intervention Type: DRUG

Patients will be randomly assigned to receive either varenicline or placebo for 45 days. Patients assigned to varenicline and are current smokers will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to varenicline and are non-smokers will receive 0.5mg by the oral route once a day for 6 days, followed by 0.5mg twice a day for 6 days. After the first 12 days the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients will be randomly assigned to receive either varenicline or placebo for 45 days. Patients assigned to varenicline and are current smokers will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to varenicline and are non-smokers will receive 0.5mg by the oral route once a day for 6 days, followed by 0.5mg twice a day for 6 days. After the first 12 days the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline.

Interventions

Varenicline

Patients will be randomly assigned to receive either varenicline or placebo for 45 days. Patients assigned to varenicline and are current smokers will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to varenicline and are non-smokers will receive 0.5mg by the oral route once a day for 6 days, followed by 0.5mg twice a day for 6 days. After the first 12 days the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline.

Intervention Type: DRUG

Placebo

Patients will be randomly assigned to receive either varenicline or placebo for 45 days. Patients assigned to varenicline and are current smokers will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to varenicline and are non-smokers will receive 0.5mg by the oral route once a day for 6 days, followed by 0.5mg twice a day for 6 days. After the first 12 days the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline.

Intervention Type: DRUG

Other Intervention Names

Chantix; chantix

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

W. Michael Hooten

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Hooten, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

11-002062

Identifier Type: -

Identifier Source: org_study_id