Trials / Withdrawn
WithdrawnNCT03244592
Minocycline for Alcohol Use Disorder
Development of Minocycline as a Neuroimmune Therapy for Alcohol Use Disorder
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of California, Los Angeles · Academic / Other
- Sex
- All
- Age
- 21 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this proposal is to advance medication development for alcohol use disorder by examining the efficacy and mechanisms of action of minocycline, a neuroimmune modulator, as a potential treatment. This study has important clinical implications, as the available treatments for alcohol use disorder are only modestly effective and testing novel medications is a high research priority.
Detailed description
The research objective of this project is to advance medication development for AUD by conducting a randomized, double blind, placebo-controlled, neuroimaging study to examine the effects of minocycline on neuroinflammation, alcohol cue reactivity, neurocognitive performance, and alcohol use. In the proposed study, non-treatment seeking individuals with a current DSM-5 AUD diagnosis (N = 32) will be randomized to receive either 200 mg of minocycline per day or placebo for 28 days and complete two laboratory sessions. The first laboratory session will be performed immediately before commencing the medication regimen (day 0) and the second will be completed after taking the medication daily for 28 days. Within each laboratory session, participants will complete a cue reactivity paradigm, neurocognitive performance tasks, and a positron emission tomography (PET) imaging session. Neuroinflammation will be assessed by using PET imaging with the radiotracer N-(2,5-dimethoxy-benzyl)-N-(5-fluoro-2-phenoxyphenyl) acetamide, labeled with carbon-11 (\[11C\]-DAA1106), which binds to the mitochondrial translocator protein, a marker of activated microglia in brain. Additionally, blood samples will be drawn on days 0, 7, 14, 21, and 28 to measure circulating levels of proinflammatory markers and alcohol use over the four weeks of treatment will also be measured.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Minocycline | 200 mg/day |
| DRUG | Sugar pill | Matched placebo |
Timeline
- Start date
- 2018-01-15
- Primary completion
- 2018-03-01
- Completion
- 2018-03-01
- First posted
- 2017-08-09
- Last updated
- 2019-01-24
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03244592. Inclusion in this directory is not an endorsement.