Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

Conditions
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Substance Withdrawal Syndrome

Intervention / Treatment
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* Drug: Tramadol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Addicted to opioids Exclusion Criteria: Any major medical or psychiatric disorder that would be contraindicated for participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tramadol 200 mg then placebo<br>Tramadol 200 mg daily for 1 week then placebo given for 1 week | Drug: Tramadol<br>* Oral Medication<br>* Other names: Brand name example: Ultram;|
| Placebo Comparator: Placebo for two weeks<br>Medication | Drug: Placebo<br>* Oral Medication<br>* Other names: Placebo is like a sugar pill;|
| Experimental: Tramadol 600 mg then placebo<br>Tramadol 600 mg daily given for 1 week given then placebo given for 1 week | Drug: Tramadol<br>* Oral Medication<br>* Other names: Brand name example: Ultram;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Opioid Withdrawal Total Adjective Score | range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T | Days 1-7 | 
| Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1 | 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. | Days 1-7 | 
| Subjective Opioid Withdrawal Adjective Total Score Week 2 | range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present | days 8-13 | 
| Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2 | 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. | Days 8-13 (all groups now on placebo) |