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The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program

NCT02431728 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-08-08

No results posted yet for this study

Summary

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.

Conditions

  • Substance Withdrawal Syndrome

Interventions

DIETARY_SUPPLEMENT

Melatonin

5 mg capsule p.o. at bedtime daily

DIETARY_SUPPLEMENT

Matched Placebo

5 mg capsule p.o. at bedtime daily

Sponsors & Collaborators

  • Duquesne University

    lead OTHER

Principal Investigators

  • Vincent Giannetti, Ph.D. · Duquesne University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02431728 on ClinicalTrials.gov