Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michelle Lofwall, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00980044
First received: September 17, 2009
Last updated: December 10, 2014
Last verified: December 2014

September 17, 2009
December 10, 2014
October 2009
February 2012   (final data collection date for primary outcome measure)
  • Subjective Opioid Withdrawal Total Adjective Score [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: days 8-13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Days 8-13 (all groups now on placebo) ] [ Designated as safety issue: No ]
    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.
Opioid Withdrawal [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00980044 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Substance Withdrawal Syndrome
  • Drug: Tramadol
    Oral Medication
    Other Name: Brand name example: Ultram
  • Drug: Placebo
    Oral Medication
    Other Name: Placebo is like a sugar pill
  • Experimental: Tramadol 200 mg then placebo
    Tramadol 200 mg daily for 1 week then placebo given for 1 week
    Intervention: Drug: Tramadol
  • Placebo Comparator: Placebo for two weeks
    Medication
    Intervention: Drug: Placebo
  • Experimental: Tramadol 600 mg then placebo
    Tramadol 600 mg daily given for 1 week given then placebo given for 1 week
    Intervention: Drug: Tramadol
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/j.drugalcdep.2013.05.010. Epub 2013 Jun 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
March 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Addicted to opioids

Exclusion Criteria:

  • Any major medical or psychiatric disorder that would be contraindicated for participation
Both
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00980044
09-0489, R01DA027068
No
Not Provided
Not Provided
Michelle Lofwall, University of Kentucky
University of Kentucky
National Institute on Drug Abuse (NIDA)
Principal Investigator: Michelle Lofwall, M.D. University of Kentucky
University of Kentucky
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP