N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Brain glutamate concentrations
Study Overview
Brief Summary
This study investigates the effects of repeated NAC administration on glutamate concentrations in the anterior cingulate cortex (ACC), on neurocognitive functioning, and on neuro-inflammatory parameters in adult cannabis-dependent individuals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Current DSM-IV diagnosis of cannabis dependence, >1 week detoxified and abstinent;
- •Able to provide written informed consent and to comply with study procedures.
- •Dutch speaking (Dutch as primary language).
Exclusion Criteria
- •Currently dependent on any substance other than cannabis, alcohol or nicotine;
- •History of any major internal disease (including diabetes, cardiovascular disease, lung disease, liver or kidney disease);
- •An active or any history of neurological disorder, including but not limited to seizure disorder, epilepsy, stroke, neurological disease, cognitive impairment, head trauma with prolonged loss of consciousness (>10 minutes), or migraine headaches;
- •An active or a history of a psychiatric disorder including, but not limited to, depression, schizophrenia, bipolar disorder, anxiety, or other psychiatric disorders;
- •Known hypersensitivity or allergy to n-acetylcysteine, or receiving chronic therapy with medication that could interact adversely with n-acetylcysteine within 30 days prior to randomization (i.e., nitroglycerin, ACE inhibitors or antihypertensive drugs, anti-coagulants);
- •Exclusion criteria for MRI: having metal in the body and/or having claustrophobia
Arms & Interventions
N-acetylcysteine
Intervention: N-acetylcysteine (Drug)
Placebo
Intervention: Neurocognitive measures (Other)
N-acetylcysteine
Intervention: Magnetic Resonance Imaging (Other)
N-acetylcysteine
Intervention: Neurocognitive measures (Other)
N-acetylcysteine
Intervention: Neuro-inflammatory measures (Other)
Placebo
Intervention: Placebo Oral Tablet (Drug)
Placebo
Intervention: Magnetic Resonance Imaging (Other)
Placebo
Intervention: Neuro-inflammatory measures (Other)
Healthy controls
Intervention: Magnetic Resonance Imaging (Other)
Healthy controls
Intervention: Neurocognitive measures (Other)
Healthy controls
Intervention: Neuro-inflammatory measures (Other)
Outcomes
Primary Outcomes
Brain glutamate concentrations
Time Frame: at study end (2 weeks after study start)
Glutamate concentrations in the anterior cingulate cortex (ACC)
Secondary Outcomes
- Attentional Bias(at study end (2 weeks after study start))
- Neuro-inflammation(at study end (2 weeks after study start))
- Motor impulsivity(at study end (2 weeks after study start))
- Cognitive impulsivity(at study end (2 weeks after study start))