None listed
Conditions
Brief summary
We will test the safety and efficacy of N-Acetyl-Cysteine (NAC) as a pharmacotherapy for methamphetamine dependence using a double-blind placebo-controlled randomised controlled trial (RCT). The trial will involve 180 participants receiving either 12 weeks of take-home oral NAC (2,400 mg daily) or equivalent placebo. There are three trial sites (Wollongong, Geelong and Melbourne). This is a Phase 2b trial that is powered to confirm whether NAC has a clinically relevant benefit on methamphetamine use and a range of related clinical outcomes. Primary hypothesis: Daily oral NAC delivered as a take home medication will reduce methamphetamine use measured as (a) days of methamphetamine use, and (b) methamphetamine in weekly saliva tests, during 12 weeks of active treatment relative to placebo. Secondary hypotheses: Daily oral NAC delivered as a take home medication will, relative to placebo: - reduce the severity of methamphetamine dependence, craving for methamphetamine, methamphetamine withdrawal symptoms and psychiatric symptoms (affective symptoms, positive psychotic symptoms and hostility), - have an acceptable adverse event profile, and - not significantly increase the use of other substances (including alcohol, tobacco, cannabis, heroin and cocaine).
Interventions
Take-home oral N-Acetyl-Cysteine, 2,400 mg per day, taken as 2 x 600 mg capsules morning and evening, for 12 weeks.
eCAP™ will be used as an objective measure of medication adherence. eCAP lids fitted to the medication bottle record the time of bottle opening, which will be downloaded at each interview using a CertiScan RFID desktop Reader or an NFC-enabled smart phone.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
• Aged between 18 and 60 years • Dependent on methamphetamine (DSM-IV current diagnosis confirmed at baseline assessment using the Composite International Diagnostic Interview) • Seeking to reduce methamphetamine use • Willing to provide contact details for their general practitioner or other treating physician and their contact details for follow-up • Able to provide informed consent and able to comply with both the requirements of the informed consent and the treatment protocol.
Exclusion criteria
• Currently enrolled in specialist treatment services for drug addiction (i.e., medically supervised detoxification, residential rehabilitation or drug counselling services, as defined in the Australian Minimum Dataset for Alcohol and Other Drug Treatment Services); this applies to the status of the participant at trial enrollment and does not preclude the participant from entering treatment or receiving usual care during the trial • Currently enrolled in other pharmacotherapy for substance use disorders (including opioid substitution therapy, nicotine replacement therapy or other pharmacotherapy for nicotine or other stimulant dependence) • In need of acute psychiatric care or an unstable psychiatric condition (e.g., suicidality or acute psychosis) • In need of acute care for intoxication or in need of medically supervised detoxification • A diagnosed primary psychotic disorder (schizophrenia, schizoaffective disorder, bipolar disorder) • Currently taking medication or other preparations that contain NAC • Contraindications for NAC: - Previous hypersensitivity to NAC - Pregnancy (confirmed at the baseline assessment) or lactation - Unwillingness to use contraception to avoid pregnancy during the trial - Currently taking medications thought to be hazardous if taken with NAC (e.g. carbamazepine, nitroglycerin) - A known or suspected active systemic medical disorder including cancer, or medical condition, that may exacerbate the risk of adverse events from NAC (recent gastro-intestinal ulcers or renal stones, epilepsy or history of seizures, asthma or atopy) - Recent surgery (within past 28 days).
Outcome results
None listed