NCT00980044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

December 3, 2014

Completed
Last Updated

April 5, 2017

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

September 17, 2009

Results QC Date

June 10, 2013

Last Update Submit

March 7, 2017

Conditions

Substance Withdrawal Syndrome

Outcome Measures

Primary Outcomes (4)

  • 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)

Study Arms (3)

Tramadol 200 mg then placebo

EXPERIMENTAL

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

Drug: Tramadol

Placebo for two weeks

PLACEBO COMPARATOR

Medication

Drug: Placebo

Tramadol 600 mg then placebo

EXPERIMENTAL

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

Drug: Tramadol

Interventions

TramadolDRUG

Oral Medication

Also known as: Brand name example: Ultram
Tramadol 200 mg then placeboTramadol 600 mg then placebo
PlaceboDRUG

Oral Medication

Also known as: Placebo is like a sugar pill
Placebo for two weeks

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Addicted to opioids

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40502, United States

Location

Related 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/j.drugalcdep.2013.05.010. Epub 2013 Jun 4.

    PMID: 23755929RESULT

MeSH Terms

Conditions

Substance Withdrawal Syndrome

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Limitations and Caveats

The study was designed to analyze only completers (12 subjects per group so the description of study participant characteristics and outcomes are from these a prior defined n=36 (12 per group) completers.

Results Point of Contact

Title
Michelle Lofwall, MD, Associate Professor
Organization
University of Kentucky College of Medicine
michelle.lofwall@uky.edu
8593239321

Study Officials

  • Michelle Lofwall, M.D.

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigatory

Study Record Dates

First Submitted

September 17, 2009

First Posted

September 18, 2009

Study Start

October 1, 2009

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

April 5, 2017

Results First Posted

December 3, 2014

Record last verified: 2017-03

Locations

US(1)