Assessment of the Level of Physical Dependence and Blockade Efficacy Produced by Tramadol
Overview
- Phase
- Phase 1
- Intervention
- Tramadol
- Conditions
- Opioid-Related Disorders
- Sponsor
- Johns Hopkins University
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Self-reported effects
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eric C. Strain
Professor
Johns Hopkins University
Eligibility Criteria
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
Arms & Interventions
1
tramadol dose 1
Intervention: Tramadol
2
tramadol dose 2
Intervention: Tramadol
Outcomes
Primary Outcomes
Self-reported effects
Time Frame: up to 4 hours for acute effects
physiologic measures
Time Frame: up to 4 hours for acute effects
observer ratings of effects
Time Frame: up to 4 hours for acute effects
cognitive/performance measures
Time Frame: up to 4 hours for acute effects