Assessment of Tramadol as a Treatment for Opioid Addiction

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eric C. Strain, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00301210
First received: March 9, 2006
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Opioid-Related Disorders
Drug: Tramadol
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Level of Physical Dependence and Blockade Efficacy Produced by Tramadol

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Self-reported effects [ Time Frame: up to 4 hours for acute effects ] [ Designated as safety issue: Yes ]
  • physiologic measures [ Time Frame: up to 4 hours for acute effects ] [ Designated as safety issue: Yes ]
  • observer ratings of effects [ Time Frame: up to 4 hours for acute effects ] [ Designated as safety issue: Yes ]
  • cognitive/performance measures [ Time Frame: up to 4 hours for acute effects ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: January 2006
Study Completion Date: November 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
tramadol dose 1
Drug: Tramadol
oral doses four times per day
Other Name: Ultram
Experimental: 2
tramadol dose 2
Drug: Tramadol
oral doses four times per day
Other Name: Ultram

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

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301210

Locations
United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Eric C. Strain, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Eric C. Strain, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00301210     History of Changes
Other Study ID Numbers: NIDA-18125-2, R01DA018125-02, DPMC
Study First Received: March 9, 2006
Last Updated: March 11, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014