Medications Development for Drug Abuse Disorders

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid Related Disorders Opioid Dependence Opioid Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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buprenorphine

Sublingual buprenorphine/naloxone tablets (or placebo)

Group Type ACTIVE_COMPARATOR

Buprenorphine/naloxone

Intervention Type DRUG

up to 8/2 mg Sublingual (SL) per day

clonidine

Oral clonidine tablets (or placebo)

Group Type ACTIVE_COMPARATOR

Clonidine

Intervention Type DRUG

up to 0.8 mg per day (oral)

tramadol ER

Oral tramadol tablets (or placebo)

Group Type EXPERIMENTAL

Tramadol ER

Intervention Type DRUG

up to 600 mg per day

Interventions

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Buprenorphine/naloxone

up to 8/2 mg Sublingual (SL) per day

Intervention Type DRUG

Clonidine

up to 0.8 mg per day (oral)

Intervention Type DRUG

Tramadol ER

up to 600 mg per day

Intervention Type DRUG

Other Intervention Names

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Suboxone Catapres Ultram

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No