Assessment of Tramadol as a Treatment for Opioid Addiction

Phase 1

Completed

• Conditions: Opioid-Related Disorders
• Interventions: Drug: Tramadol

• Registration Number: NCT00301210
• Lead Sponsor: Johns Hopkins University

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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-03-09
• Study First Submitted QC: 2006-03-09
• Study First Posted: 2006-03-10
• Primary Completion: 2007-10
• Study Completion: 2007-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Tramadol	tramadol dose 1
2	Tramadol	tramadol dose 2

Primary Outcome Measures

Name	Time	Method
Self-reported effects	up to 4 hours for acute effects
physiologic measures	up to 4 hours for acute effects
observer ratings of effects	up to 4 hours for acute effects
cognitive/performance measures	up to 4 hours for acute effects

Trial Locations

Locations (1)

Behavioral Pharmacology Research Unit; 🇺🇸 Baltimore, Maryland, United States