N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms

• ClinicalTrials.gov Identifier: NCT03221231
• Recruitment Status: Unknown
• First Posted: July 18, 2017
• Last Update Posted: October 24, 2018
• Sponsor: Universitair Ziekenhuis Brussel
• Information provided by (Responsible Party): Universitair Ziekenhuis Brussel

Tracking Information

• First Submitted Date: June 19, 2017
• First Posted Date: July 18, 2017
• Last Update Posted Date: October 24, 2018
• Actual Study Start Date: May 15, 2016
• Estimated Primary Completion Date: February 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 13, 2017)

Brain glutamate concentrations [ Time Frame: at study end (2 weeks after study start) ]

Glutamate concentrations in the anterior cingulate cortex (ACC)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 13, 2017)

• Motor impulsivity [ Time Frame: at study end (2 weeks after study start) ]
  Stop Signal Reaction Time (SSRT) on the Stop Signal Task
• Cognitive impulsivity [ Time Frame: at study end (2 weeks after study start) ]
  Indifference point measured by a Monetary Delayed Discounting Task
• Attentional Bias [ Time Frame: at study end (2 weeks after study start) ]
  Difference in response time for incongruent-congruent stimuli on a Stroop task
• Neuro-inflammation [ Time Frame: at study end (2 weeks after study start) ]
  Concentration of interleukin in blood

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
• Official Title: N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

RCT

Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science

Condition

• Cannabis Use Disorder
• Cannabis Dependence

Intervention

• Drug: N-acetylcysteine
  1200 mg/day, twice daily, N-acetylcysteine
• Drug: Placebo Oral Tablet
  twice daily, placebo
• Other: Magnetic Resonance Imaging
• Other: Neurocognitive measures
• Other: Neuro-inflammatory measures

Study Arms

• Experimental: N-acetylcysteine
  Interventions:

  • Drug: N-acetylcysteine
  • Other: Magnetic Resonance Imaging
  • Other: Neurocognitive measures
  • Other: Neuro-inflammatory measures
• Placebo Comparator: Placebo
  Interventions:

  • Drug: Placebo Oral Tablet
  • Other: Magnetic Resonance Imaging
  • Other: Neurocognitive measures
  • Other: Neuro-inflammatory measures
• Active Comparator: Healthy controls
  Interventions:

  • Other: Magnetic Resonance Imaging
  • Other: Neurocognitive measures
  • Other: Neuro-inflammatory measures

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 13, 2017): 75
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 1, 2019
• Estimated Primary Completion Date: February 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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;
• 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT03221231
• Other Study ID Numbers: 131115
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Universitair Ziekenhuis Brussel
• Study Sponsor: Universitair Ziekenhuis Brussel
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Universitair Ziekenhuis Brussel
• Verification Date: June 2017