Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

NCT ID: NCT00980044

Last Updated: 2017-04-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Substance Withdrawal Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tramadol 200 mg then placebo

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

Group Type EXPERIMENTAL

Tramadol

Intervention Type DRUG

Oral Medication

Placebo for two weeks

Medication

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral Medication

Tramadol 600 mg then placebo

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

Group Type EXPERIMENTAL

Tramadol

Intervention Type DRUG

Oral Medication

Interventions

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Tramadol

Oral Medication

Intervention Type DRUG

Placebo

Oral Medication

Intervention Type DRUG

Other Intervention Names

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Brand name example: Ultram Placebo is like a sugar pill

Eligibility Criteria

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Inclusion Criteria

* Addicted to opioids

Exclusion Criteria

* Any major medical or psychiatric disorder that would be contraindicated for participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Michelle Lofwall

OTHER

Sponsor Role lead

Responsible Party

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Michelle Lofwall

Principal Investigatory

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michelle Lofwall, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23755929 (View on PubMed)

Other Identifiers

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R01DA027068

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09-0489

Identifier Type: -

Identifier Source: org_study_id

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