Cannabis dependence
Conditions
Interventions
Trade Name: Acetylcysteine
Product Name: acetylcysteine
Pharmaceutical Form: Powder and solvent for oral solution
Pharmaceutical form of the placebo: Powder and solvent for oral solution
Route of admi
Sponsors
University Hospital Brussels (UZ Brussel)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Males, aged 18-45 years; • Current DSM-IV diagnosis of cannabis dependence, >1 week detoxified and abstinent; • Able to provide written informed consent and to comply with study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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; • Asthma; • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to investigate the working mechanism of the pharmacological agent n-acetylcysteine (NAC) in the treatment of cannabis-dependence. The primary aim is to investigate the effect of NAC on brain glutamate concentrations in treatment-seeking cannabis-dependent individuals. ;Secondary Objective: The secondary aim is to investigate the effects of NAC on impulse control, motivational strength of drug cues, and brain activation patterns in cannabis-dependent individuals, and to examine the anti-inflammatory activity of NAC on cortical neuro-inflammatory parameters in cannabis-dependent individuals. ;Primary end point(s): Because the objective is to understand the working mechanisms of acetylcysteine, the primary endpoint is identical for all participants: following 2-week administration of acetylcysteine or placebo. ;Timepoint(s) of evaluation of this end point: 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium
Contacts
Public ContactDpt of Psychiatry / C.L. Crunelle
University Hospital Brussels (UZ Brussel)
Outcome results
None listed