Assessment of Tramadol as a Treatment for Opioid Addiction

Study Overview
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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.

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

Conditions
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Opioid-Related Disorders

Intervention / Treatment
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* Drug: Tramadol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>tramadol dose 1 | Drug: Tramadol<br>* oral doses four times per day<br>* Other names: Ultram;|
| Experimental: 2<br>tramadol dose 2 | Drug: Tramadol<br>* oral doses four times per day<br>* Other names: Ultram;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |