Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

Grants and Contracts Details

Description

The study's specific aims remain unchanged from the initial approved proposal. This pilot project proposes to evaluate extended release tramadol (Uitram ER®) for the treatment of prescription opioid withdrawal. The 2- week inpatient study will employ a randomized, placebo-controlled, double-blind parallel group design. There are two specific aims, one for each week of the study. During the first week (Phase 1 ), the specific aim is to determine the dose-related efficacy of ER tramadol in suppressing prescription opioid withdrawal. During the second week (Phase 2), the specific aim is to determine the characteristics and magnitude of opioid withdrawal from ER tramadol after acute dosing cessation. Prescription opioid dependent individuals, who are healthy and willing to live on the University of Kentucky residential research unit, will be enrolled after careful medical and psychiatric screening. Volunteers will be admitted to the inpatient unit and the following morning (after a period of opioid abstinence) will be stratified based on three levels of observed-opioid withdrawal (low, medium, and high) and randomized to one of three drug conditions: placebo, ER tramadol 200 mg daily, or ER tramadol600 mg daily (n=12 completers per group). Doses are ascending over the first 24-hours and maintained at the target dose through day 7 in order to assess Specific Aim #1. During the second week of the study (days 8-14), all groups take placebo (double-blind) in order to assess Specific Aim #2. Concomitant medications are available for breakthrough withdrawal during both phases. A broad array of measures, including measures of observer- and subject-rated opioid withdrawal and agonist effects, mood, pain, cognition, drug craving, medication side effects, and vital signs are repeatedly collected each day. The primary outcome measures for both phases are participant-rated Opioid Adjectives Rating Questionnaire Withdrawal Scale scores and number of doses of concomitant medications taken. Secondary outcome measures include observer-rated opioid withdrawal scores, cognitive task performance, pain and mood ratings, medication side effects, and vital signs. This study will provide preliminary safety and efficacy data on the potential utility of tramadol ER for treating prescription opioid dependence and determine whether a larger-scale evaluation is warranted.
StatusFinished
Effective start/end date8/15/097/31/13

Funding

  • National Institute on Drug Abuse: $124,366.00

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