Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Substance Withdrawal Syndrome

In brief

Prescription opioid addiction is a growing public health problem and more pharmacologic treatments are needed because current approved medications have had limited patient acceptance (naltrexone), limited availability (methadone), and concerns about misuse and diversion (methadone and buprenorphine). Tramadol is a currently approved medication used to treat moderate-severe pain, and initial studies demonstrate that it may be useful for treatment of the uncomfortable syndrome of opioid withdrawal without producing euphoric effects. This study will determine whether two different doses of extended release tramadol can treat opioid withdrawal and whether tramadol itself produces withdrawal after it is no longer taken.

Key facts

Study ID

NCT00980044

Run by

Michelle Lofwall

People needed

53

Starts

2009-10-01

Expected to finish

2012-03-01

Last updated by the study team

2017-04-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Addicted to opioids

You may not qualify if…

• Any major medical or psychiatric disorder that would be contraindicated for participation

Where it is running

• University of Kentucky — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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