NCT01436474 - Pilot Study of Varenicline to Treat Opioid Dependence | Crick

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

21

Conditions

Chronic Pain Opioid Dependence

Interventions

VareniclineDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 45 days