Medications Development for Drug Abuse Disorders
This trial has been completed.
|Conditions||opioid related disorders, opioid dependence, opioid addiction|
|Treatments||buprenorphine/naloxone, clonidine, tramadol er|
|Phase||phase 1/phase 2|
|Sponsor||Johns Hopkins University|
|Collaborator||National Institute on Drug Abuse (NIDA)|
|Start date||October 2010|
|End date||June 2015|
|Trial size||106 participants|
|Trial identifier||NCT01188421, DPMC, NA_00037871, NIDA-018125, R01DA018125|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
change between groups over time in scores on a standard measure of opioid withdrawal signs and symptoms
time frame: daily for approximately 4 weeks
Male or female participants from 18 years up to 60 years old.
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.
|Official title||Medications Development for Drug Abuse Disorders|
|Principal investigator||Eric C. Strain, M.D.|
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