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Completed

NCT Number: NCT01188421

Medications Development for Drug Abuse Disorders

This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A randomized, double blind clinical trial comparing the efficacy and safety of tramadol to clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be conducted. Opioid dependent participants will be treated on a residential unit. The primary outcome measure is opioid withdrawal symptoms.

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Key information

Conditions

Opioid Related Disorders Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Addiction Opioid Dependence Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Johns Hopkins University (BPRU) Bayview Campus

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion/Exclusion Criteria:

  • Participants in this study will be males and females between the ages of 18 and 60 years.
  • Applicants must be opioid dependent based upon the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (SCID); in addition, they must have an opioid positive urine during the screening process (or have evidence of opioid withdrawal).
  • They must be healthy, with no significant medical illnesses (e.g., insulin dependent diabetes), and without significant psychiatric illness (e.g., schizophrenia) besides their drug dependence.
  • Females will have a pregnancy test prior to study enrollment, and if found to be pregnant will be excluded and referred to a substance abuse program for pregnant women (the Center for Addiction and Pregnancy) on the campus.
  • Volunteers will also be excluded if they have pre-admission hypotension (due to the use of clonidine in the study).
  • Applicants with a history of seizures (including substance-related seizures, such as alcohol withdrawal related) will be excluded.
  • Alcohol and/or sedative dependence will be specific exclusionary criteria (given the small risk of seizures associated with tramadol use).
  • Allergies to any of the study medications will be grounds for exclusion.

Treatment and study plan

buprenorphine/naloxone

Drug

up to 8/2 mg Sublingual (SL) per day

Other names: Suboxone

Clonidine

Drug

up to 0.8 mg per day (oral)

Other names: Catapres

tramadol ER

Drug

up to 600 mg per day

Other names: Ultram

Primary outcomes

  1. Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.

    Time frame: 14 days total

    Outcomes represent mean peak withdrawal as rated on the Clinical Opiate Withdrawal Scale (COWS) total score. Withdrawal was collected 7 times daily and daily peak values were identified for each participant and averaged together as a function of group. Primary outcomes were mean peak results from the 7-day taper period and first 7 days post-taper. The COWS is an 11-item observer-rated measure of opioid withdrawal severity. Items are rated on individual Likert scales and the total score range is 0-47. Higher values indicate more severe withdrawal.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2010
Registry last updated
Jul 6, 2017

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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