Medications Development for Drug Abuse Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Johns Hopkins University
Information provided by (Responsible Party):
Eric C. Strain, Johns Hopkins University Identifier:
First received: August 11, 2010
Last updated: May 4, 2013
Last verified: May 2013

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.

Condition Intervention Phase
Opioid Related Disorders
Opioid Dependence
Opioid Addiction
Drug: Buprenorphine/naloxone
Drug: Clonidine
Drug: Tramadol ER
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medications Development for Drug Abuse Disorders

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]
    Participants in this study will be assessed for opioid withdrawal on a daily basis. The primary outcome measure for this assessment is the Clinical Opioid Withdrawal Scale (COWS), which is a well-established clinical assessment tool for quantifying the different signs and symptoms of opioid withdrawal. The COWS has been validated, and scores can range from 0 to 47. It is administered by a clinician on the ward.

Estimated Enrollment: 150
Study Start Date: October 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: buprenorphine Drug: Buprenorphine/naloxone
up to 8/2 mg SL per day
Active Comparator: clonidine Drug: Clonidine
up to 0.8 mg per day (oral)
Experimental: tramadol Drug: Tramadol ER
up to 600 mg per day


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01188421

Contact: Hye Han 410-550-0490

United States, Maryland
Johns Hopkins University (BPRU) Bayview Campus Recruiting
Baltimore, Maryland, United States, 21224
Contact: Hye Han    410-550-0490   
Contact: Hye Han   
Principal Investigator: Eric C. Strain, M.D.         
Sub-Investigator: David A. Tompkins, M.D.         
Sub-Investigator: George E. Bigelow, Ph.D.         
Sub-Investigator: Miriam Z. Mintzer, Ph.D.         
Sub-Investigator: Kelly Dunn, Ph.D.         
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Eric C. Strain, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Eric C. Strain, Professor, Johns Hopkins University Identifier: NCT01188421     History of Changes
Other Study ID Numbers: NIDA-018125, NA_00037871, R01DA018125, DPMC
Study First Received: August 11, 2010
Last Updated: May 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders processed this record on March 26, 2015