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Medications Development for Drug Abuse Disorders

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid Related Disorders; Opioid Dependence; Opioid Addiction

Intervention: Buprenorphine/naloxone (Drug); Clonidine (Drug); Tramadol ER (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Eric C. Strain, M.D., Principal Investigator, Affiliation: Johns Hopkins University

Overall contact:
Hye Han, Phone: 410-550-0490, Email: hhan9@jhu.edu


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.

Clinical Details

Official title: Medications Development for Drug Abuse Disorders

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: change between groups over time in scores on a standard measure of opioid withdrawal signs and symptoms


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion/Exclusion Criteria:

- Participants in this study will be males and females between the ages of 18 and 60


- 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.

Locations and Contacts

Hye Han, Phone: 410-550-0490, Email: hhan9@jhu.edu

Johns Hopkins University (BPRU) Bayview Campus, Baltimore, Maryland 21224, United States; Recruiting
Hye Han, Phone: 410-550-0490, Email: hhan9@jhu.edu
Hye Han, Email: hhan9@jhu.edu
Eric C. Strain, M.D., Principal 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., Sub-Investigator
Additional Information

Starting date: October 2010
Last updated: April 16, 2015

Page last updated: August 23, 2015

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