Phase 3
N=53
Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
Substance Withdrawal Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00980044 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Subjective Opioid Withdrawal Total Adjective Score — 5.8; 7.7; 6.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tramadol (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Michelle Lofwall
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Opioid Withdrawal Total Adjective Score |
5.8; 7.7; 6.9 | — |
| PRIMARY Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1 |
1.8; 2.5; 3.1 | — |
| PRIMARY Subjective Opioid Withdrawal Adjective Total Score Week 2 |
2.7; 2.9; 2.7 | — |
| PRIMARY Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2 |
1.8; 1.6; 3.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Addicted to opioids
Exclusion Criteria
- Any major medical or psychiatric disorder that would be contraindicated for participation
Data sourced from ClinicalTrials.gov (NCT00980044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.