Medications Development for Drug Abuse Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01188421
Recruitment Status : Completed
First Posted : August 25, 2010
Results First Posted : July 6, 2017
Last Update Posted : July 6, 2017
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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 or disease Intervention/treatment Phase
Opioid Related Disorders Opioid Dependence Opioid Addiction Drug: Buprenorphine/naloxone Drug: Clonidine Drug: Tramadol ER Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medications Development for Drug Abuse Disorders
Study Start Date : October 2010
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: buprenorphine
Sublingual buprenorphine/naloxone tablets (or placebo)
Drug: Buprenorphine/naloxone
up to 8/2 mg Sublingual (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

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Johns Hopkins University Identifier: NCT01188421     History of Changes
Other Study ID Numbers: NIDA-018125
NA_00037871 ( Other Identifier: JHUSOM IRB )
R01DA018125 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: August 25, 2010    Key Record Dates
Results First Posted: July 6, 2017
Last Update Posted: July 6, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Substance-Related Disorders
Opioid-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