Clinical trial NCT02431728: The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program
Official title: The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program: A Randomized, Double Blind, Placebo, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Substance Withdrawal Syndrome
Keywords: Melatonin
Post-acute withdrawal symptoms
Anxiety
Depression
Insomnia
Stress
Substance withdrawal syndrome
Lead sponsor: Duquesne University
Sponsor class: OTHER
First posted: 2015-05-01
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The effect of melatonin or placebo on the change in anxiety as measured by the Generalized Anxiety Disorder (GAD-7) scale
timeFrame: Baseline, Day 7, Day 14, Day 21, Day 28
measure: The effect of melatonin or placebo on the change in depressive symptoms as measured by the Personal Health Questionnaire Depression Scale (PHQ-8)
timeFrame: Baseline, Day 7, Day 14, Day 21, Day 28
measure: The effect of melatonin or placebo on the change in sleep symptoms as measured by the Pittsburgh Sleep Symptom Questionnaire - Insomnia (PSSQ-1)
timeFrame: Baseline, Day 7, Day 14, Day 21, Day 28
measure: The effect of melatonin or placebo on the change in stress as measured by the Perceived Stress Scale (PSS-14)
timeFrame: Baseline, Day 7, Day 14, Day 21, Day 28
Secondary outcomes:
measure: Patient health histories (social, medical, medication, preventive, and mental health)
timeFrame: Baseline
measure: The number of reported adverse effects
timeFrame: Day 7, Day 14, Day 21, Day 28
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Salvation Army Harbor Light Center
state: Pennsylvania
Study officials:
affiliation: Duquesne University
name: Vincent Giannetti, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: