Status:
COMPLETED
Medications Development for Drug Abuse Disorders
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Related Disorders
Opioid Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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 buprenorphi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01188421
Start Date
October 1 2010
End Date
June 1 2015
Last Update
July 6 2017
Active Locations (1)
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1
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, United States, 21224