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Medications Development for Drug Abuse Disorders

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Eric C. Strain, Johns Hopkins University Identifier:
First received: August 11, 2010
Last updated: December 20, 2016
Last verified: December 2016
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]
    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.

Enrollment: 106
Study Start Date: October 2010
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: buprenorphine
Sublingual buprenorphine/naloxone tablets (or placebo)
Drug: Buprenorphine/naloxone
up to 8/2 mg SL per day
Other Name: Suboxone
Active Comparator: clonidine
Oral clonidine tablets (or placebo)
Drug: Clonidine
up to 0.8 mg per day (oral)
Other Name: Catapres
Experimental: tramadol ER
Oral tramadol tablets (or placebo)
Drug: Tramadol ER
up to 600 mg per day
Other Name: Ultram


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.
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Please refer to this study by its identifier: NCT01188421

United States, Maryland
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Eric C. Strain, M.D. Johns Hopkins University
  More Information

Responsible Party: Eric C. Strain, Professor, Johns Hopkins University Identifier: NCT01188421     History of Changes
Other Study ID Numbers: NIDA-018125
NA_00037871 ( Other Identifier: JHUSOM IRB )
R01DA018125 ( US NIH Grant/Contract Award Number )
DPMC ( Other Identifier: NIDA )
Study First Received: August 11, 2010
Last Updated: December 20, 2016

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 25, 2017