Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

Substance Withdrawal Syndrome Clinical Trial

Official title:

Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980044
• Other study ID #: 09-0489
• Secondary ID: R01DA027068
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 17, 2009
• Last updated: December 10, 2014
• Start date: October 2009
• Est. completion date: March 2012

Study information

• Verified date: December 2014
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Addicted to opioids

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance Withdrawal Syndrome

Intervention

Drug:
• Tramadol
Oral Medication
• Placebo
Oral Medication

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Kentucky	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lofwall MR, Babalonis S, Nuzzo PA, Siegel A, Campbell C, Walsh SL. Efficacy of extended-release tramadol for treatment of prescription opioid withdrawal: a two-phase randomized controlled trial. Drug Alcohol Depend. 2013 Nov 1;133(1):188-97. doi: 10.1016/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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)	No