Title: A clinical remission study of low-severity alcohol use disorder, treated with nalmefene
When someone develops an alcohol use disorder (AUD), their addiction does not go away simply by refraining from drinking for some weeks or months. On the contrary, due to the deprivation effect, if one day they try to have just one alcoholic drink they will feel a strong and imperative biological necessity to keep drinking very fast, not being able to stop, which will lead to immediate negative consequences.
The good news is that opiod receptor antagonists, such as naltrexone and nalmefene, have shown efficacy for reducing the deprivation effect, and for reducing alcohol consumption, in people who suffer from low-severity alcohol use disorders.
Alcohol use disorders may turn into a persistent and relapsing disease. Many patients stop drinking easily, even without treatment, when they are overwhelmed by their “problems” associated with heavy drinking. Afterwards they may remain in remission for weeks or months. However, relapses may be devastating either for patients or for their families. The hypothesis of this study is that the self-monitoring treatment program with nalmefene may obtain a fast, significant, and continued reduction in alcohol consumption, without negative consequences in low- severity AUD patients.
We included AUD patients meeting DSM-5 criteria. Those who showed an alcohol withdrawal syndrome or an unstable medical, psychiatric or addictive comorbidity disorder (except tobacco use disorder), were considered high severity AUD, and they were excluded.
Low-severity AUD patients followed a self-monitoring outpatient treatment program, assisted with nalmefene, with a goal to reduce alcohol consumption for 12 weeks. They came to 4 visits (baseline, 4th week, 8th week and 12th week). After the baseline assessment visit, they began to take one 18 milligram tablet of nalmefene each day, and from the second week of treatment they chose to take it daily or “as needed”.
Outcome variables are (1) total monthly alcohol consumption, (2) daily average alcohol consumption, (3) the score of DrinC Inventory (assessing negative consequences of heavy drinking) and (4) biological markers of heavy drinking, such as gamma-glutamil transpeptidase (GGT), mean corpuscular volume (MCV) and carbohydrate deficient transferrin (CDT). Variables (1), (2) and (3), were assessed baseline and monthly, and GGT, MVC and CDT, baseline and at the end of the study treatment.
Thirty AUD patients have been included in the study, 18 men and 12 women. Ages between 31 and 72 years old, mean 50.73 (+ 11,41) years old. Half of them, 15 patients, completed the 12 week study and the other half dropped out before study completion. Total alcohol consumption, average daily alcohol consumption, and DrinC score differed statistically significantly between baseline and the other time points. Post-hoc tests revealed a statistically significant decrease in these three variables from pre-treatment to 4th week, 8th week, and 12th week of treatment. However, post-hoc comparisons between successive time points (i.e., 4th week vs. 8th week, and 8th week vs. 12th week of treatment) did not reach statistical significance.
Mean total (monthly) alcohol consumption decreased from 1887 (baseline) to 813.8 grams of pure alcohol at the 4th week, and to 695 grams at 12th week. Mean average daily alcohol consumption decreased from 69.65 to 29 grams per day at the 4th week, and to 24.57 grams per day at the 12th week. And mean DrinC score decreased from 15.7 (baseline) to 3.43 at the 4th week, and to 3.13 at the 12th week. And these differences are statistically significant.
The three biological markers of heavy drinking showed a decrease from baseline to the 12th week, which reached statistical significance for MCV, but not for GGT or CDT.
The results of this study confirm that low-severity AUD patients, who followed the self-monitoring treatment program with a reduction oriented goal, assisted with nalmefene, obtained a fast, significant and sustained reduction of alcohol consumption, and at the same time, of negative consequences of heavy drinking, during the whole three months of treatment with nalmefene.
Furthermore, if low-severity AUD patients treated with nalmefene reach and maintain a low-level of risk alcohol consumption pattern, and if their negative consequences associated to heavy drinking disappear, they may be considered in clinical remission.