Alcohol Dependence
Conditions
Brief summary
The study will explore the efficacy and tolerability of a regimen of NAC (2400 mg) versus placebo for the treatment of alcohol dependence.
Detailed description
Study 1: Relapse prevention: This is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive oral NAC (2400 mg: 2x 600mg tablets twice per day) or matching placebo. Trial participants will receive either oral NAC ( dose stated above) or matching placebo for up to 4 weeks. Study 2: Withdrawal: Trial participants will receive oral NAC (dose stated above) or matching placebo within the first 24 hours of their admission for up to 3 days. Study 3: Participants from the relapse prevention substudy will also receive 30-minute non-invasive brain imaging session prior to and after completing the treatment regime in Study 1. Both males and females will be recruited for the study.
Interventions
DRUGNAC 2400mg/day
2400mg/day 2 x 600mg b.d
DRUGPlacebo
4 matched placebo tablets/day
Sponsors
National Health and Medical Research Council, Australia
University of Sydney
South West Sydney Local Health District
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Study 1: NAC vs Placebo (PL) (4 weeks outpatient) Study 2: NAC vs PL (3 days inpatient) Study 2: NAC vs PL (neuromaging session before vs after treatment)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female patients between the ages of 18 and 65 meeting DSM-IV criteria for current alcohol use disorder (this is an exclusion for the healthy control sample) * Able to understand and sign written informed consent * Must have a stable residence and be able to identify an individual who could locate subject if needed * Admitted for medical detoxification from alcohol (withdrawal study only) * Blood alcohol concentration of 0.00 (if completing brain imaging session) * Express a desire to achieve abstinence or to greatly reduce alcohol consumption (relapse prevention study only)
Exclusion criteria
* Clinically significant comorbidities or medical disease that might interfere with the evaluation of the study medication or present a safety concern. * Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control * Women who are breastfeeding * Dependence on any substance other than nicotine * Court-mandated participation in alcohol treatment or pending incarceration (relapse prevention study only) * Treatment/ingestion during the previous week of benzodiazepines or other sedative-hypnotic medications or history of recent chronic treatment with sedative-hypnotic medications (withdrawal study only) * Dependence on any substance other than nicotine The following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study 1: Alcohol consumption | 4 weeks | as measured by the number of heavy drinking days per week and number of drinks per drinking day |
| Study 2: Amount of Benzodiazepines administered | 3 days | as measured by the number of benzodiazepines administered in the NAC vs placebo groups |
| Study 3: Markers of neural inflammation and responses to alcohol cue | 4 weeks | as measured by differences in cortical levels of glutathione |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol craving | 4 weeks | as measured by Penn Alcohol Craving Scale (PACS) score |
| Mood | 4 weeks | as measured by Depression Anxiety Stress Scale (DASS) score |
Countries
Australia
Contacts
Primary ContactKirsten Morley, PhD
Outcome results
None listed