Mylan School of Pharmacy and the Graduate School of Pharmaceutical Sciences
anxiety, chemical dependency, depression, melatonin, sleep difficulties, substance use
The study goal was to assess melatonin as an adjuvant treatment along with current pharmaco- and behavioral therapy for 28 days on weekly self-reported severity of anxiety, depression, stress, and sleep complaints as well as how sleep is affecting daily life in a sample of males in recovery from chemical dependency at a single, residential treatment site, Salvation Army Harbor Light Center in Pittsburgh, PA. This study was a single-center, randomized, double-blind, placebo-controlled, parallel group trial of 28 days. Participants were randomized to melatonin (5 mg) or placebo and instructed to administer the intervention nightly at bedtime. Primary self-reported outcome measures of severity of anxiety, depression, stress, as well as sleep complaints and how sleep is affecting daily life were assessed on a weekly basis with the Generalized Anxiety Disorder Scale (GAD-7), Personal Health Questionnaire Depression Scale (PHQ-8), Perceived Stress Scale (PSS-14), and Pittsburgh Sleep Symptom Questionnaire – Insomnia (PSSQ-1). Secondary outcome measures were to acquire participant histories, determine adherence as well as adverse events. Seventy participants (age 21 – 65, mean 40.4 ± 11 years) were enrolled with 24 completing the study in each group. Demographically, the sample consisted of those who identified as white (70%), single (74.3%), and with an education level of high school/G.E.D. or less (77.1%). Intention-to-treat analysis for all outcome measures revealed statistically significant within-groups differences over time for both groups. The study failed to demonstrate statistically between-group differences for these measures. Also, complete case analysis for each week revealed no between-group differences. Additionally, the change from Baseline and Day 28 as determined by a response of an improvement of 50% or higher in scores for each scale revealed no significant strength of association between the groups when considering worst case for the loss to follow-up. Melatonin appeared to be well tolerated with similar adverse events reported as placebo; however, there was a tendency to report more vivid dreams/nightmares as well as next day tiredness/grogginess/sleepiness. Clinical investigations into the use of melatonin as a treatment for depression, anxiety, stress, and sleep difficulties in those recovering from illicit and non-illicit drug dependency are limited and larger studies are warranted. Possible future directions include a study design that is multicenter, the inclusion of a therapy only arm, assessing various doses and timelines, assessing effects in adolescents or females, or limiting inclusion based on prescribed medications, mental health status, medical conditions, prior melatonin use, and/or a specific chemical dependency. Overall, this is the first and largest randomized, double-blind, placebo-controlled, parallel group trial assessing the effects of melatonin upon post-acute withdrawal among males in a residential treatment program. However, the various analyses indicated insufficient evidence to suggest that melatonin and placebo were significantly different, and it may be concluded, based upon the study sample, design, and its limitations, the effect of melatonin on the assessed measures was no different than placebo. Due to the heterogeneity of the participants as evidenced by the participant histories, there exists a possibility of a Type II error that must be considered and not overlooked.
Bondi, C. (2016). The Effect of Melatonin Upon Post-Acute Withdrawal Among Males in a Residential Treatment Program (M-Paws): A Randomized, Double-Blind, Placebo Controlled Trial (Doctoral dissertation, Duquesne University). Retrieved from http://ddc.duq.edu/etd/46
Available for download on Wednesday, December 20, 2017