Medications Development for Drug Abuse Disorders

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: Buprenorphine/naloxone
  • up to 8/2 mg SL per day
• Drug: Clonidine
  • up to 0.8 mg per day (oral)
• Drug: Tramadol ER
  • up to 600 mg per day

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: buprenorphine
• Active Comparator: clonidine
• Experimental: tramadol

Primary Measures

• change between groups over time in scores on a standard measure of opioid withdrawal signs and symptoms
  • Time Frame: daily for approximately 4 weeks
    Safety Issue?: Yes

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
• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Johns Hopkins University Other

Overall Clinical Trial Officials and Contacts

Eric C. Strain, M.D. Principal Investigator Johns Hopkins University  

Overall Contact: Sarah Ilk 410-550-0159 silk1@jhmi.edu

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01188421

Study ID Number: NIDA-018125

ClinicalTrials.gov Identifier: NCT01188421

Health Authority: United States: Food and Drug Administration