Pilot Study of Varenicline to Treat Opioid Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W. Michael Hooten, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01436474
First received: June 3, 2011
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Chronic Pain
Opioid Dependence
Drug: Varenicline
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Role of Varenicline in Treating Opioid Dependence: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • assessment of opioid withdrawal symptoms [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
    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

  • Assessment of cravings at one month following opioid tapering [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
    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


Enrollment: 21
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varenicline
We will be comparing Varenicline to placebo in a single-blinded placebo controlled, randomized study
Drug: 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.
Other Name: Chantix
Placebo Comparator: 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.
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.
Other Name: chantix

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436474

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: William Hooten, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: W. Michael Hooten, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01436474     History of Changes
Other Study ID Numbers: 11-002062
Study First Received: June 3, 2011
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Varenicline
Chantix
Chronic Pain
Opioid dependence

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Analgesics, Opioid
Varenicline
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014