Overview

This trial is active, not recruiting.

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 December 2015
Trial size 150 participants
Trial identifier NCT01188421, DPMC, NA_00037871, NIDA-018125, R01DA018125

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Sublingual buprenorphine/naloxone tablets (or placebo)
buprenorphine/naloxone Suboxone
up to 8/2 mg SL per day
(Active Comparator)
Oral clonidine tablets (or placebo)
clonidine Catapres
up to 0.8 mg per day (oral)
(Experimental)
Oral tramadol tablets (or placebo)
tramadol er Ultram
up to 600 mg per day

Primary Outcomes

Measure
change between groups over time in scores on a standard measure of opioid withdrawal signs and symptoms
time frame: daily for approximately 4 weeks

Eligibility Criteria

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.

Additional Information

Official title Medications Development for Drug Abuse Disorders
Principal investigator Eric C. Strain, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Johns Hopkins University.