Recommended Conditions for Use in Alcohol Dependence Alcohol abstinence at treatment initiation Alcohol abstinence at treatment initiation Patients willing to receive monthly injections Patients with difficulty adhering to an oral regimen to Alcohol abstinence at treatment initiation Most clinical trials have evaluated acamprosate therapy concomitantly with some type of psychosocial therapy Abstinence is the treatment goal Abstinence > 24 and / or blood or breath alcohol level is zero Failure of or contraindication to naltrexone Previous response to disulfiram Capacity to appreciate risks and benefits and to consent to treatment Note: Most effective with monitored administration (e.g., in clinic or with spouse or probation officer.) Use in patients with concomitant cocaine dependence can be considered case by case. Considerations for Use Pretreatment abstinence from alcohol is not required but improves response May be efficacious for reducing heavy drinking (small effect size) Most trials for oral NTX required as an inclusion criterion pretreatment abstinence of ≥ 4 or ≥ 7 days. This is the subgroup of patients in which oral NTX was shown to be efficacious. Pretreatment abstinence from alcohol is not required but improves response Greater benefit may be seen in patients who achieve some duration of alcohol abstinence (e.g. 2–4 days) prior to the initial injection of naltrexone. May support abstinence in patients, who are already abstinent (small to moderate effect size) Limited data available on comparative efficacy and safety
Common Adverse Effects (≥ 10%) Nausea Injection-site reaction, tenderness, induration Nausea Headache Asthenic conditions Anxiety Insomnia Abdominal pain Diarrhea Vomiting Pharyngitis Anorexia Diarrhea Somnolence Metallic taste Headache Other Adverse Effects Headache Dizziness Nervousness Fatigue Insomnia Vomiting Anxiety Somnolence Depression Somnolence Dry mouth Anxiety Asthenia Depression Insomnia Drug Interactions Opioid-containing medications, including OTC preparations Thioridazine (increased lethargy and somnolence) Opioid-containing medications, including OTC preparations Thioridazine (increased lethargy and somnolence) Naltrexone: 33% increase in Cmax of acamprosate (no dosage adjustment is recommended) Antidepressants: weight gain and weight loss more common than with either medication alone Alcohol containing medications, including OTC preparations Drug-drug interactions may occur with phenytoin, warfarin, isoniazid, rifampin, diazepam, chlordiazepoxide, imipramine, desipramine, and oral hypoglycemic agents Monitoring Ongoing alcohol use, craving, medication adherence, adverse effects, emerging symptoms (e.g., depression, suicidality), biomarkers of unhealthy alcohol use (e.g., blood pressure, gamma glutamyl transferase (GGT), mean corpuscular volume (MCV), HbA1c, carbohydrate-deficient transferrin (CDT)) Repeat liver transaminases at 6 and 12 months and then every 12 months thereafter Efficacy and safety beyond 8 months is unclear; after 8 months, reassess patient regularly for adverse effects and need for continuation of therapy Repeat liver transaminases at 6 and 12 months and then every 12 months thereafter Serum creatinine / CrCl, at baseline and as clinically indicated thereafter, particularly in patients with renal impairment and the elderly Efficacy and safety beyond 1 year of treatment is uncertain; after 1 year, reassess patient regularly for adverse effects and need for continuation of therapy Repeat liver transaminases in 10 to 14 days, monthly for 3 months, and every 12 months thereafter CBC, serum chemistries, liver transaminases / LFTs