Alcohol use and misuse is a global problem with severe health consequences. Alcohol consumption is the causal factor in more than 200 disease and injury conditions and is responsible for over 3.3 million deaths worldwide every year.
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Acamprosate, a medication licensed for use in 25 countries including the United States, works to suppress alcohol cravings by inhibiting elevated glutamatergic neurotransmission.
In Japan, routine clinical practice for alcohol dependence treatment differs greatly from practices in the United States and Europe; patients are hospitalized for 2 months for treatment of withdrawal and post-acute withdrawal symptoms and for stabilization which is then followed by continuing outpatient rehabilitation. The Japanese Acamprosate Study Group conducted a double-blind, randomized, placebo-controlled trial to evaluate the efficacy of acamprosate for maintaining complete abstinence after the 2-month index treatment episode in Japanese patients meeting ICD-10 criteria for alcohol dependence.
Eligible patients were randomized to oral acamprosate (n = 163) or matched placebo (n = 164) for 24 weeks beginning the day after discharge from inpatient therapy. Participants were followed for an additional 24 weeks after the end of the active treatment phase. Patients received additional therapies including individual or group psychotherapy and referral to self-help groups.
Authors used a rigorous multi-method approach to verify alcohol consumption or abstinence, based on diary entries, interviews with subjects and attendants (i.e., collateral report with someone 20 years or older that lived with the participant), breath alcohol concentration, and laboratory liver functions tests. Participants were 87% male, 52 years old on average, and over half had a duration of alcohol dependence spanning less than 10 years. Patients were not eligible if they had a history of other drug use or misuse, or if they had a psychiatric disorder that required pharmacological treatment.
Regarding the primary outcome, 47% of the acamprosate group and 36% of the placebo group achieved complete abstinence during the 24-week treatment phase.
There were no significant differences between groups in terms of number of days of cumulative abstinence during the treatment period.
In support of the evidence from the European randomized control trials (RCTs), results in the current study were similar to those from trials in the United States and Europe where the study drug was initiated immediately after treatment of withdrawal symptoms (versus in Japan where participants were free of withdrawal syndrome and abstinent for the two months spent in inpatient therapy prior to starting the trial).
Thus, acamprosate appears to have an effect despite patients being in a different stage of recovery. This study also employed rigorous methods to ensure reliable data through the use of daily participant diaries and cooperative attendants. The authors reported that 92% of participants attended scheduled study visits and 99% of cooperative attendants attended scheduled visits or were able to be contacted by telephone. Furthermore, biological markers were used for confirmation, providing more confidence in these results.
Other outcomes such as percent days abstinent should also be explored as they may provide valuable information on differences between treatment groups.
Higuchi, S. (2015). Efficacy of acamprosate for the treatment of alcohol dependence long after recovery from withdrawal syndrome: a randomized, double-blind, placebo-controlled study conducted in Japan (sunrise study). The Journal of clinical psychiatry, 76(2), 181-188.
l
Acamprosate, a medication licensed for use in 25 countries including the United States, works to suppress alcohol cravings by inhibiting elevated glutamatergic neurotransmission.
In Japan, routine clinical practice for alcohol dependence treatment differs greatly from practices in the United States and Europe; patients are hospitalized for 2 months for treatment of withdrawal and post-acute withdrawal symptoms and for stabilization which is then followed by continuing outpatient rehabilitation. The Japanese Acamprosate Study Group conducted a double-blind, randomized, placebo-controlled trial to evaluate the efficacy of acamprosate for maintaining complete abstinence after the 2-month index treatment episode in Japanese patients meeting ICD-10 criteria for alcohol dependence.
Eligible patients were randomized to oral acamprosate (n = 163) or matched placebo (n = 164) for 24 weeks beginning the day after discharge from inpatient therapy. Participants were followed for an additional 24 weeks after the end of the active treatment phase. Patients received additional therapies including individual or group psychotherapy and referral to self-help groups.
Authors used a rigorous multi-method approach to verify alcohol consumption or abstinence, based on diary entries, interviews with subjects and attendants (i.e., collateral report with someone 20 years or older that lived with the participant), breath alcohol concentration, and laboratory liver functions tests. Participants were 87% male, 52 years old on average, and over half had a duration of alcohol dependence spanning less than 10 years. Patients were not eligible if they had a history of other drug use or misuse, or if they had a psychiatric disorder that required pharmacological treatment.
Regarding the primary outcome, 47% of the acamprosate group and 36% of the placebo group achieved complete abstinence during the 24-week treatment phase.
There were no significant differences between groups in terms of number of days of cumulative abstinence during the treatment period.
In support of the evidence from the European randomized control trials (RCTs), results in the current study were similar to those from trials in the United States and Europe where the study drug was initiated immediately after treatment of withdrawal symptoms (versus in Japan where participants were free of withdrawal syndrome and abstinent for the two months spent in inpatient therapy prior to starting the trial).
Thus, acamprosate appears to have an effect despite patients being in a different stage of recovery. This study also employed rigorous methods to ensure reliable data through the use of daily participant diaries and cooperative attendants. The authors reported that 92% of participants attended scheduled study visits and 99% of cooperative attendants attended scheduled visits or were able to be contacted by telephone. Furthermore, biological markers were used for confirmation, providing more confidence in these results.
Other outcomes such as percent days abstinent should also be explored as they may provide valuable information on differences between treatment groups.
Higuchi, S. (2015). Efficacy of acamprosate for the treatment of alcohol dependence long after recovery from withdrawal syndrome: a randomized, double-blind, placebo-controlled study conducted in Japan (sunrise study). The Journal of clinical psychiatry, 76(2), 181-188.
l
Acamprosate, a medication licensed for use in 25 countries including the United States, works to suppress alcohol cravings by inhibiting elevated glutamatergic neurotransmission.
In Japan, routine clinical practice for alcohol dependence treatment differs greatly from practices in the United States and Europe; patients are hospitalized for 2 months for treatment of withdrawal and post-acute withdrawal symptoms and for stabilization which is then followed by continuing outpatient rehabilitation. The Japanese Acamprosate Study Group conducted a double-blind, randomized, placebo-controlled trial to evaluate the efficacy of acamprosate for maintaining complete abstinence after the 2-month index treatment episode in Japanese patients meeting ICD-10 criteria for alcohol dependence.
Eligible patients were randomized to oral acamprosate (n = 163) or matched placebo (n = 164) for 24 weeks beginning the day after discharge from inpatient therapy. Participants were followed for an additional 24 weeks after the end of the active treatment phase. Patients received additional therapies including individual or group psychotherapy and referral to self-help groups.
Authors used a rigorous multi-method approach to verify alcohol consumption or abstinence, based on diary entries, interviews with subjects and attendants (i.e., collateral report with someone 20 years or older that lived with the participant), breath alcohol concentration, and laboratory liver functions tests. Participants were 87% male, 52 years old on average, and over half had a duration of alcohol dependence spanning less than 10 years. Patients were not eligible if they had a history of other drug use or misuse, or if they had a psychiatric disorder that required pharmacological treatment.
Regarding the primary outcome, 47% of the acamprosate group and 36% of the placebo group achieved complete abstinence during the 24-week treatment phase.
There were no significant differences between groups in terms of number of days of cumulative abstinence during the treatment period.
In support of the evidence from the European randomized control trials (RCTs), results in the current study were similar to those from trials in the United States and Europe where the study drug was initiated immediately after treatment of withdrawal symptoms (versus in Japan where participants were free of withdrawal syndrome and abstinent for the two months spent in inpatient therapy prior to starting the trial).
Thus, acamprosate appears to have an effect despite patients being in a different stage of recovery. This study also employed rigorous methods to ensure reliable data through the use of daily participant diaries and cooperative attendants. The authors reported that 92% of participants attended scheduled study visits and 99% of cooperative attendants attended scheduled visits or were able to be contacted by telephone. Furthermore, biological markers were used for confirmation, providing more confidence in these results.
Other outcomes such as percent days abstinent should also be explored as they may provide valuable information on differences between treatment groups.
Higuchi, S. (2015). Efficacy of acamprosate for the treatment of alcohol dependence long after recovery from withdrawal syndrome: a randomized, double-blind, placebo-controlled study conducted in Japan (sunrise study). The Journal of clinical psychiatry, 76(2), 181-188.
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