The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2015 |
| End Date: | December 2015 |
| Contact: | Vincent Giannetti, Ph.D. |
| Email: | giannett@duq.edu |
The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program: A Randomized, Double Blind, Placebo, Controlled Trial
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients already taking melatonin
- Adverse history with melatonin supplementation
We found this trial at
1
site
Click here to add this to my saved trials
