Pilot Study of Varenicline to Treat Opioid Dependence

NCT01436474 | Completed Phase 1 DMC

• 1 other identifier: 11-002062
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

Varenicline; Chantix; Chronic Pain; Opioid dependence

Outcome Measures

Primary Outcomes (2)

• assessment of opioid withdrawal symptoms

  During their treatment, patients are closely monitored by a multidisciplinary team, and there are regular assessments of pain, depression, substance use, and pain-related physical and emotional functioning

  45 days

• Assessment of cravings at one month following opioid tapering

  During their treatment, patients are closely monitored by a multidisciplinary team, and there are regular assessments of pain, depression, substance use, and pain-related physical and emotional functioning

  45 days

Study Arms (2)

Varenicline

EXPERIMENTAL

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

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Varenicline 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.

Also known as: Chantix

Varenicline

Placebo 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.

Also known as: chantix

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• William Hooten, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: September 19, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

US (1)