Pilot Study of Varenicline to Treat Opioid Dependence

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

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

Conditions
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Chronic Pain, Opioid Dependence

Intervention / Treatment
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* Drug: Varenicline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varenicline<br>We will be comparing Varenicline to placebo in a single-blinded placebo controlled, randomized study | Drug: Varenicline<br>* 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.<br>* Other names: Chantix;|
| Placebo Comparator: Placebo<br>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<br>* 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.<br>* Other names: chantix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varenicline, Chantix, Chronic Pain, Opioid dependence