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Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

Primary Purpose

Substance Withdrawal Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tramadol
Placebo
Sponsored by
Michelle Lofwall
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Withdrawal Syndrome

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Addicted to opioids

Exclusion Criteria:

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Tramadol 200 mg then placebo

Placebo for two weeks

Tramadol 600 mg then placebo

Arm Description

Tramadol 200 mg daily for 1 week then placebo given for 1 week

Medication

Tramadol 600 mg daily given for 1 week given then placebo given for 1 week

Outcomes

Primary Outcome Measures

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
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2009
Last Updated
March 7, 2017
Sponsor
Michelle Lofwall
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00980044
Brief Title
Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
Official Title
Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michelle Lofwall
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Withdrawal Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tramadol 200 mg then placebo
Arm Type
Experimental
Arm Description
Tramadol 200 mg daily for 1 week then placebo given for 1 week
Arm Title
Placebo for two weeks
Arm Type
Placebo Comparator
Arm Description
Medication
Arm Title
Tramadol 600 mg then placebo
Arm Type
Experimental
Arm Description
Tramadol 600 mg daily given for 1 week given then placebo given for 1 week
Intervention Type
Drug
Intervention Name(s)
Tramadol
Other Intervention Name(s)
Brand name example: Ultram
Intervention Description
Oral Medication
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo is like a sugar pill
Intervention Description
Oral Medication
Primary Outcome Measure Information:
Title
Subjective Opioid Withdrawal Total Adjective Score
Description
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T
Time Frame
Days 1-7
Title
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1
Description
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.
Time Frame
Days 1-7
Title
Subjective Opioid Withdrawal Adjective Total Score Week 2
Description
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present
Time Frame
days 8-13
Title
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2
Description
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.
Time Frame
Days 8-13 (all groups now on placebo)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Addicted to opioids Exclusion Criteria: Any major medical or psychiatric disorder that would be contraindicated for participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Lofwall, M.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23755929
Citation
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.
Results Reference
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Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

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