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Medications Development for Drug Abuse Disorders

NCT01188421 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2017-07-06

Study results available
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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.

Conditions

Interventions

DRUG

Buprenorphine/naloxone

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

DRUG

Clonidine

up to 0.8 mg per day (oral)

DRUG

Tramadol ER

up to 600 mg per day

Sponsors & Collaborators

Principal Investigators

  • Eric C. Strain, M.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01188421 on ClinicalTrials.gov