Assessment of Tramadol as a Treatment for Opioid Addiction

NCT ID: NCT00301210

Last Updated: 2015-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-11-30

Brief Summary

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Opioids are one of the most commonly abused drugs among individuals who seek treatment for drug abuse. Thus, it is necessary to develop new treatments for opioid addiction. The purpose of this trial is determine whether tramadol is effective in treating opioid dependent individuals.

Detailed Description

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This human laboratory study will test the effects of tramadol as a step in its development as a new treatment for opioid dependence. Tramadol is a moderate mu agonist opioid that may produce low levels of opioid physical dependence. Tramadol's capacity for producing physical dependence has not been systematically studied in humans. It is important to quantify tramadol, as it provides a measure of its opioid agonist effects. This would also be informative in regards to the abuse liability of tramadol when used as an analgesic (as currently marketed), or when used in the treatment of opioid addiction (as proposed in this study). The purpose of this trial is to evaluate the level of physical dependence as well as blockade efficacy produced by chronic maintenance on oral tramadol in opioid dependent individuals.

Participants will be randomly assigned to receive different doses of tramadol or placebo for up to six weeks. Experimental sessions will take place up to three times per week during the treatment period. During challenge sessions, participants will receive an injection; four different kinds of effects may occur in a session following this injection. First, no effect may occur (a placebo). Second, an opioid agonist effect may occur (opioid agonists include heroin, morphine, hydromorphone, tramadol, and methadone), which may cause the participant to feel "high." Third, an opioid antagonist effect may occur (e.g., naloxone, naltrexone), which may cause the participant to feel a sense of opioid withdrawal.

Conditions

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Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

tramadol dose 1

Group Type EXPERIMENTAL

Tramadol

Intervention Type DRUG

oral doses four times per day

2

tramadol dose 2

Group Type EXPERIMENTAL

Tramadol

Intervention Type DRUG

oral doses four times per day

Interventions

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Tramadol

oral doses four times per day

Intervention Type DRUG

Other Intervention Names

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Ultram

Eligibility Criteria

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Inclusion Criteria

* Currently opioid dependent

Exclusion Criteria

* Significant medical illness (e.g., diabetes mellitus)
* History of seizure
* Current sedative or alcohol dependence
* Pregnant or breastfeeding
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Eric C. Strain

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric C. Strain, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Lanier RK, Lofwall MR, Mintzer MZ, Bigelow GE, Strain EC. Physical dependence potential of daily tramadol dosing in humans. Psychopharmacology (Berl). 2010 Sep;211(4):457-66. doi: 10.1007/s00213-010-1919-3. Epub 2010 Jun 30.

Reference Type RESULT
PMID: 20589494 (View on PubMed)

Other Identifiers

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R01DA018125-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DPMC

Identifier Type: -

Identifier Source: secondary_id

NIDA-18125-2

Identifier Type: -

Identifier Source: org_study_id

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