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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


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
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