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Completed

NCT Number: NCT01436474

Pilot Study of Varenicline to Treat Opioid Dependence

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

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Chantix

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.

Other names: chantix

Primary outcomes

  1. assessment of opioid withdrawal symptoms

    Time frame: 45 days

    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

  2. Assessment of cravings at one month following opioid tapering

    Time frame: 45 days

    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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Role of Varenicline in Treating Opioid Dependence: A Pilot Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 19, 2011
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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