Medications Development for Drug Abuse Disorders

Johns Hopkins University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Opioid Addiction; Opioid Dependence; Opioid Related Disorders

Treatments: Drug: Clonidine; Drug: Buprenorphine/naloxone; Drug: Tramadol ER

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01188421

R01DA018125 (U.S. NIH Grant/Contract)

NA_00037871 (Other Identifier)

DPMC

NIDA-018125

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 3 patient groups

buprenorphine

Active Comparator group

Description:

Sublingual buprenorphine/naloxone tablets (or placebo)

Treatment:

Drug: Buprenorphine/naloxone

clonidine

Active Comparator group

Description:

Oral clonidine tablets (or placebo)

Treatment:

Drug: Clonidine

tramadol ER

Experimental group

Description:

Oral tramadol tablets (or placebo)

Treatment:

Drug: Tramadol ER