None listed
Conditions
Brief summary
This project aims to explore the safety and effectiveness of lithium carbonate in reducing the severity of withdrawal that often occurs with the cessation of dependent cannabis use. Participants will be admitted to an inpatient drug treatment unit for 7 days and will be randomly assigned to receive either lithium or placebo.
Interventions
This project aims to explore the safety and effectiveness of lithium carbonate in reducing the severity of withdrawal that often occurs on cessation of dependent cannabis use. The trial will utilise a double-blind, randomised, placebo controlled design. Participants will be admitted to an inpatient drug treatment unit for 7 days and will be randomly assigned to receive either lithium or placebo. Participants randomised to the treatment condition will be administered two capsules containing 250mg
This project aims to explore the safety and effectiveness of lithium carbonate in reducing the severity of withdrawal that often occurs on cessation of dependent cannabis use. The trial will utilise a double-blind, randomised, placebo controlled design. Participants will be admitted to an inpatient drug treatment unit for 7 days and will be randomly assigned to receive either lithium or placebo. Participants randomised to the treatment condition will be administered two capsules containing 250mg lithium carbonate twice a day (i.e., 1000mg per day) for 6 days.
Sponsors
Brain & Mind Research Institute (BMRI), University of Sydney
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* At least (=) 18 years of age. * Meet Diagnostic Statistical Manual of Mental Disorders (DSM)-IV-TR criteria for cannabis dependence. * Have identified withdrawal symptoms as a barrier to achieving abstinence from cannabis.
Exclusion criteria
* People who are alcohol dependent. This will be assessed by clinical assessment * People who use drugs other than cannabis, caffeine and tobacco more than twice weekly, or inject drugs more than once per week (on average) in the 30 days prior to recruitment. * People on methadone or buprenorphine treatment for opioid dependence. * People with documented lactose intolerance. * People with a documented intolerance of lithium. * People with a history of schizophrenia, bipolar affective disorder or recent psychosis (within preceding 3 months); or admission to mental health unit within the 3 months prior to recruitment. * People assessed as being at significant risk of suicide. * People with renal or thyroid function outside the normal range. People with severe liver disease (as identified by clinical assessment and liver function tests (Gamma Glutamyl Transpeptidase (GGT), Aspartate Transaminase (AST) and Alanine Transaminase (ALT) levels 3-fold above the normal range). This will be assessed prior to study entry. * People with significant cardiovascular disease (myocardial infarction in past 6 months, cardiomyopathy, significant hypertension (> 180/120), major arrhythmias). Assessed clinically and by electrocardiography (ECG) in those >45 years of age. * People with current prescriptions (within past month) for mood stabilising medications (e.g., Valproate and Carbamazepine). * People with current prescriptions (within past month) for antidepressant and/or antipsychotic medications assessed as clinically unstable. * Females who are breastfeeding or pregnant at recruitment (screened using blood test for human chorionic gonadotropin (hCG) in women of child bearing potential), or planning on becoming pregnant or not using adequate contraception in the month following study entry.
Outcome results
None listed