The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Substance Withdrawal Syndrome
In brief
Individuals recovering from drug and/or alcohol addiction initially experience the symptoms of acute withdrawal before experiencing the symptoms of post-acute withdrawal (PAWS). PAWS include a wide array of emotional and psychological symptoms such as anxiety, sleep disturbances, depression, and stress. Previous studies have shown that melatonin therapy was beneficial to alleviate anxiety, depressive symptoms, and sleep disturbances. However, no randomized, double-blind, placebo controlled trials have been conducted in males who are experiencing PAWS. The purpose of this study is to investigate the effect of 5 mg melatonin given nightly for four weeks on weekly assessed, self-reported anxiety, depressive symptoms, insomnia, and stress in males with PAWS who reside in a residential treatment center.
Key facts
- Study ID
- NCT02431728
- Run by
- Duquesne University
- People needed
- 70
- Starts
- 2015-05-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2016-08-08
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Males 18 years of age and older who are actively participating in therapy at a residential treatment program
- Willingness to participate in the 4-week study
- Willingness to provide self-reported demographic, social, medical, medication, preventive, and mental health histories
- Willingness to complete self-assessments of anxiety, depression, insomnia, and stress at designated time intervals
- Willingness to administer daily before bed a capsule containing either 5 mg melatonin plus vegetable fiber filler or only the vegetable fiber filler without melatonin (i.e., the matched placebo).
- English speaking
You may not qualify if…
- Patients already taking melatonin
- Adverse history with melatonin supplementation
Where it is running
- Salvation Army Harbor Light Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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