NCT01188421

Medications Development for Drug Abuse Disorders

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

• Opioid Related Disorders
• Opioid Dependence
• Opioid Addiction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-10-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2010-08-25
• Last updated: 2017-07-06
• Results posted: 2017-07-06

Locations

1 site across 1 country: United States