Clinical trial NCT00301210: Assessment of Tramadol as a Treatment for Opioid Addiction
Official title: Assessment of the Level of Physical Dependence and Blockade Efficacy Produced by Tramadol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-03-10
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Self-reported effects
timeFrame: up to 4 hours for acute effects
measure: physiologic measures
timeFrame: up to 4 hours for acute effects
measure: observer ratings of effects
timeFrame: up to 4 hours for acute effects
measure: cognitive/performance measures
timeFrame: up to 4 hours for acute effects
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric C. Strain, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.