Assessment of Tramadol as a Treatment for Opioid Addiction

Opioid-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301210
• Other study ID #: NIDA-18125-2
• Secondary ID: R01DA018125-02DP
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 9, 2006
• Last updated: April 16, 2015
• Start date: January 2006
• Est. completion date: November 2007

Study information

• Verified date: April 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Tramadol
oral doses four times per day

Locations

Country	Name	City	State
United States	Behavioral Pharmacology Research Unit	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported effects		up to 4 hours for acute effects	Yes
Primary	physiologic measures		up to 4 hours for acute effects	Yes
Primary	observer ratings of effects		up to 4 hours for acute effects	Yes
Primary	cognitive/performance measures		up to 4 hours for acute effects	Yes