Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Placebo for two weeks	Placebo	Medication
Tramadol 200 mg then placebo	Tramadol	Tramadol 200 mg daily for 1 week then placebo given for 1 week
Tramadol 600 mg then placebo	Tramadol	Tramadol 600 mg daily given for 1 week given then placebo given for 1 week

Primary Outcome Measures

Name	Time	Method
Subjective Opioid Withdrawal Total Adjective Score	Days 1-7	range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1	Days 1-7	There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.
Subjective Opioid Withdrawal Adjective Total Score Week 2	days 8-13	range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2	Days 8-13 (all groups now on placebo)	There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.