Cannabis Use DisorderPhase 4NCT03221231
N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
A Phase 4 study testing N-acetylcysteine, Magnetic Resonance Imaging and Neurocognitive measures in people with Cannabis Use Disorder and Cannabis Dependence, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use Disorder, Cannabis Dependence
- What is being tested?
- N-acetylcysteine, Magnetic Resonance Imaging and Neurocognitive measures
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteBelgium
- Study dates
- 15 May 2016to 1 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Cleo L Crunelle, PhD contact
F Matthys PhD contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Brussels
Brussels, 1090
Cleo L Crunelle, PhD, nacstudie@gmail.com
About this study
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.
- Conditions
- Cannabis Use Disorder, Cannabis Dependence
- Being tested
- N-acetylcysteine, Placebo Oral Tablet, Magnetic Resonance Imaging, Neurocognitive measures, Neuro-inflammatory measures
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
1200 mg/day, twice daily, N-acetylcysteine
Placebo Oral TabletDrug
twice daily, placebo
Magnetic Resonance ImagingOther
Neurocognitive measuresOther
Neuro-inflammatory measuresOther
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Experimental | Not described Receives: Drug: N-acetylcysteine; Other: Magnetic Resonance Imaging; Other: Neurocognitive measures; Other: Neuro-inflammatory measures |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet; Other: Magnetic Resonance Imaging; Other: Neurocognitive measures; Other: Neuro-inflammatory measures |
| Healthy controls | Active comparator | Not described Receives: Other: Magnetic Resonance Imaging; Other: Neurocognitive measures; Other: Neuro-inflammatory measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain glutamate concentrations
Glutamate concentrations in the anterior cingulate cortex (ACC)
Measured: at study end (2 weeks after study start)
Secondary outcomes (4)
Motor impulsivity
Stop Signal Reaction Time (SSRT) on the Stop Signal Task
Measured: at study end (2 weeks after study start)
Cognitive impulsivity
Indifference point measured by a Monetary Delayed Discounting Task
Measured: at study end (2 weeks after study start)
Attentional Bias
Difference in response time for incongruent-congruent stimuli on a Stroop task
Measured: at study end (2 weeks after study start)
Neuro-inflammation
Concentration of interleukin in blood
Measured: at study end (2 weeks after study start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start15 May 2016
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221231
- Sponsor's protocol ID
- 131115
- Status last verified
- Dec 2020
- First submitted
- 19 Jun 2017
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
- ClinicalTrials.gov ID
- NCT03221231
- Acronym / sponsor ID
- 131115
- Conditions
- Cannabis Use Disorder, Cannabis Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 15 May 2016 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Experimental | Drug: N-acetylcysteine, Other: Magnetic Resonance Imaging, Other: Neurocognitive measures, Other: Neuro-inflammatory measures |
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet, Other: Magnetic Resonance Imaging, Other: Neurocognitive measures, Other: Neuro-inflammatory measures |
| Healthy controls | Active comparator | Other: Magnetic Resonance Imaging, Other: Neurocognitive measures, Other: Neuro-inflammatory measures |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteine1200 mg/day, twice daily, N-acetylcysteine | Drug | N-acetylcysteine |
| Placebo Oral Tablettwice daily, placebo | Drug | Placebo |
| Magnetic Resonance Imaging | Other | Healthy controls, N-acetylcysteine, Placebo |
| Neurocognitive measures | Other | Healthy controls, N-acetylcysteine, Placebo |
| Neuro-inflammatory measures | Other | Healthy controls, N-acetylcysteine, Placebo |
Primary outcome
Brain glutamate concentrations
Time frame: at study end (2 weeks after study start)
Glutamate concentrations in the anterior cingulate cortex (ACC)
4 secondary outcomes
Motor impulsivity
Time frame: at study end (2 weeks after study start)
Cognitive impulsivity
Time frame: at study end (2 weeks after study start)
Attentional Bias
Time frame: at study end (2 weeks after study start)
Neuro-inflammation
Time frame: at study end (2 weeks after study start)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cleo L Crunelle, PhD contact
F Matthys PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N-acetylcysteine, Magnetic Resonance Imaging and Neurocognitive measures in people with Cannabis Use Disorder and Cannabis Dependence, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cleo L Crunelle, PhD (nacstudie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain glutamate concentrations (time frame: at study end (2 weeks after study start)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.