The Effects of Minocycline in Opioid-maintained Patients

Completed · Not applicable · Has a placebo group

Conditions studied: Opioid Dependence, Pain

In brief

Opioids are the most commonly utilized pharmacological treatment for moderate to severe pain. However, their clinical value is hindered by the development of opioid-induced hyperalgesia (OIH). OIH manifests as heightened pain sensitivity, and is an increasingly challenging drawback to the efficacy of opioid treatment. Although the mechanism of action modulating OIH is not completely understood, previous animal studies suggest that this phenomenon is a result of proinflammatory responses. Thus, administering an adjunct anti-inflammatory agent may attenuate OIH. Minocycline is one such agent; it is a tetracycline derivative antibiotic that inhibits microglia activation, nitric oxide (NO) production, and the release of pro-inflammatory cytokines and chemokines. In fact, recent evidence suggests that minocycline may attenuate the neuroinflammatory effects of opioids while enhancing their antinociceptive effects. Therefore, the investigators will determine if minocycline will mitigate OIH in methadone-maintained patients.

Key facts

Study ID

NCT02359006

Run by

Yale University

People needed

27

Starts

2015-03-12

Expected to finish

2017-04-19

Last updated by the study team

2020-03-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, between the ages of 18 and 55
• Diagnosed with opioid dependence and currently enrolled in methadone maintenance treatment
• Compliant in methadone maintenance treatment and on a stable dose for two weeks or greater
• No current dependence or abuse of any other drugs (other than tobacco or marijuana)
• No current medical problems
• For women:
• not pregnant as determined by pregnancy screening;
• not breast feeding; u
• using acceptable birth control methods;
• not experiencing moderate to severe premenstrual symptoms (may interfere with pain assessment);
• regular menstrual cycles

You may not qualify if…

• Current major psychiatric illnesses including mood, psychotic, or anxiety disorders
• History of major medical illnesses, including liver diseases, heart disease, or other medical conditions that the physician investigator deems contraindicated for inclusion in the study
• Current use of over-the-counter or prescription psychoactive drugs (including regular use of NSAIDS, antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, Percocet, and other opiate drugs
• Liver function tests (ALT or AST) greater than 3x normal
• Allergy to minocycline or other tetracyclines

Where it is running

• VA Hospital — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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