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

NCT ID: NCT02431728

Last Updated: 2016-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-01-31

Brief 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.

Detailed Description

Approval was obtained from the Institutional Review Board at Duquesne University prior to the study implementation. The trial was a single-center, randomized, double-blind, matched placebo-controlled, parallel-group trial conducted in males 18 years of age and older who are in a residential treatment program for chemical dependency at the Salvation Army Harbor Light Center (865 West North Avenue, Pittsburgh, Pennsylvania, 15233) in the United States of America. Convenience sampling was used to recruit individuals from July 2015 to December 2015. A total sample of 70 participants were enrolled and block randomized with an allocation ratio of 1:1 for the interventions. Financial compensation of $5.00 U.S. was initiated at Day 7 and continued at each follow-up (Day 14, Day 21 & Day 28). Intention-to-treat and complete case analyses were conducted. No interim analysis was performed to assess efficacy. Participants completed study materials in a designated room at the center.

Briefly, this study involved the completion of four validated surveys assessing self-reported perceived severity of anxiety (Generalized Anxiety Disorder Scale; GAD-7), depression (Personal Health Questionnaire Depression Scale; PHQ-8), stress (Perceived Stress Scale; PSS-14), sleep complaints and how is sleep affecting daily life (Pittsburgh Sleep Symptom Questionnaire - Insomnia; PSSQ-1) at five time points (Baseline, Day 7, Day 14, Day 21, and Day 28). To address any adverse events relating to the interventions, the participant was encouraged to report any perceived adverse events to the investigator. To protect the anonymity and confidentiality of the participants, all paperwork were de-identified but contained their unique identification number.

Conditions

Substance Withdrawal Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Melatonin

capsule containing 5mg melatonin plus cellulose

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

5 mg capsule p.o. at bedtime daily

Matched Placebo

capsule containing cellulose

Group Type: PLACEBO_COMPARATOR

Matched Placebo

Intervention Type: DIETARY_SUPPLEMENT

5 mg capsule p.o. at bedtime daily

Interventions

Melatonin

5 mg capsule p.o. at bedtime daily

Intervention Type: DIETARY_SUPPLEMENT

Matched Placebo

5 mg capsule p.o. at bedtime daily

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

N-acetyl-5-methoxytryptamine; Vegetable fiber

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Duquesne University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Giannetti, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duquesne University

Locations

Salvation Army Harbor Light Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

DuquesneU

Identifier Type: -

Identifier Source: org_study_id