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Randomized Controlled Trial
. 2020 May 26;10(1):8739.
doi: 10.1038/s41598-020-65166-y.

Melatonin for Treatment-Seeking Alcohol Use Disorder patients with sleeping problems: A randomized clinical pilot trial

Marie N S Gendy  1   2 , Dina Lagzdins  1 , Jessika Schaman  3 , Bernard Le Foll  4   5   6   7   8   9   10
Affiliations
Randomized Controlled Trial

Melatonin for Treatment-Seeking Alcohol Use Disorder patients with sleeping problems: A randomized clinical pilot trial

Marie N S Gendy et al. Sci Rep. .

Abstract

A high percentage of subjects diagnosed with alcohol use disorder (AUD) suffer from sleeping difficulties. Lack of sleep could lead AUD patients to relapse or, sometimes, to suicide. Most of the currently prescribed medications to treat this complex problem retain a high risk of side effects and/or dependence. Therefore, the aim of the current clinical trial is to investigate the possibility of the use of a safer treatment, such as the natural health product melatonin, to treat alcohol-related sleeping problems. Sixty treatment-seeking AUD subjects were assigned to melatonin (5 mg) or placebo for 4 weeks of treatment. Change in sleeping quality which is the primary outcome of the study was assessed using the Pittsburgh sleep quality index (PSQI) scale. Linear mixed models were used to statistically analyze the difference in scores before and after 4 weeks of treatment. There was a reduction in the global PSQI score in both groups with no significant drug effect between groups. In conclusion, the use of melatonin (5 mg)/day didn't differ from placebo in decreasing sleeping problems in a sample of AUD subjects after 4 weeks of treatment. However, higher doses are worth exploring in future research.

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Conflict of interest statement

Dr. Le Foll has/will received some in-kind donation of cannabis product from Canopy and Aurora and medication donation from Pfizer and Bioprojet and was provided a coil for TMS study from Brainsway. Dr. Le Foll has/will perform research with industry funding obtained from Canopy, Bioprojet, ACS and Alkermes. Dr. Le Foll has received in kind donations of nabiximols from GW Pharma for past studies funded by CIHR and NIH. The other authors declared no conflict of interest.

Figures

Figure 1
Figure 1
CONSORT Flow Chart.
Figure 2
Figure 2
Main outcomes: PSQI, BDI, BAI scores before and after treatment expressed as Mean ± SD. All scores significantly decreased over time for the placebo group from baseline (black bars) to after treatment (2nd pattern bars). Also, the same scores decreased over time for the melatonin group from baseline (grey bars) to after treatment (4thpattern bars). No significant difference between groups was detected (p > 0.05).
Figure 3
Figure 3
PSQI subscales, (components expressed as Mean ± SD), showed a significant decrease over time for the placebo group from baseline (black bars) to after treatment (2nd pattern bars). Also the scores showed a significant decrease over time for the melatonin group from baseline (grey bars) to after treatment (4thpattern bars). No significant difference between groups was detected (p > 0.05). Component # (6), which is the use of hypnotic sedative medication, is not shown in this figure as it was considered zero for this study.
See this image and copyright information in PMC

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