Assessment of Tramadol as a Treatment for Opioid Addiction - Tabular View

Tracking Information

First Received Date ^ICMJE

March 9, 2006

Last Updated Date

August 13, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Self-reported effects [ Time Frame: up to 4 hours for acute effects ] [ Designated as safety issue: Yes ]
physiologic measures [ Time Frame: up to 4 hours for acute effects ] [ Designated as safety issue: Yes ]
observer ratings of effects [ Time Frame: up to 4 hours for acute effects ] [ Designated as safety issue: Yes ]
cognitive/performance measures [ Time Frame: up to 4 hours for acute effects ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Self-reported effects
physiologic measures
observer ratings of effects
cognitive/performance measures

Change History

Complete list of historical versions of study NCT00301210 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Assessment of Tramadol as a Treatment for Opioid Addiction

Official Title ^ICMJE

Assessment of the Level of Physical Dependence and Blockade Efficacy Produced by Tramadol

Brief Summary

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

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.

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study

Condition ^ICMJE

Opioid-Related Disorders

Intervention ^ICMJE

Drug: Tramadol

Study Arms / Comparison Groups

Experimental: tramadol dose 1
Experimental: tramadol dose 2

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00301210

Responsible Party

Eric C. Strain/Principal Investigator, Johns Hopkins University School of Medicine

Study ID Numbers ^ICMJE

NIDA-18125-2, DPMC

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Eric C. Strain, MD

Johns Hopkins University

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

August 2008

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