Trials / Recruiting
RecruitingNCT05445180
Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use
Investigating the Neural Correlates of Cognitive Function Associated With Cannabis Abstinence in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- Sponsor
- Douglas Mental Health University Institute · Academic / Other
- Sex
- All
- Age
- 16 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
Cognitive impairment is well established in people with psychosis and is associated with cannabis use. The current study will investigate the neurobiological basis of cognitive change associated with 28-days of cannabis abstinence in people with psychosis and non-psychiatric controls with cannabis use. Participants will be randomized to a cannabis abstinent group or a non-abstinent control group and will undergo magnetic resonance imaging at baseline and following 28-days of abstinence. This study will help characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use and its recovery which may guide the development of novel interventions for problematic cannabis use.
Detailed description
Background/Importance: Cognitive impairment is well established in people with psychosis and is associated with cannabis use. Despite high rates of cannabis use among people with psychosis and the general population, cannabis' effects on cognition and the brain and their recovery remain unclear. Therefore, this study will investigate the neurobiological basis of changes in cognitive processes associated with cannabis abstinence in people with psychosis and non-psychiatric controls. Aims: To examine the effects of 28-days of cannabis abstinence in psychosis patients with cannabis use and non-psychiatric controls with cannabis use on (i) brain activity (paired with a memory task); (ii) brain morphology; (iii) to determine if changes in memory following 28-days of abstinence correlate with changes in brain activity and/or morphology and (iv) to determine if baseline brain function and morphology can predict successful abstinence. Methods: Seventy-four psychosis patients with cannabis use and 60 non-psychiatric controls with cannabis use will be randomized to: (1) contingency reinforcement where biochemically verified abstinence at day 28 will be rewarded; or (2) a non-abstinent control group. The investigators will also recruit a group of healthy non-psychiatric controls (n=40) to determine if neural outcomes in cannabis-using participants do indeed normalize ("recover") following abstinence. Participants will undergo structural and functional magnetic resonance imaging while completing a memory task at baseline (pre-abstinence) and following 28-days of abstinence. Urine samples will be collected twice weekly for abstinence verification. Relevance: This study will help to characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use in people with psychosis and non-psychiatric controls which may help to guide the development of novel neurobiologically-informed interventions to treat problematic cannabis use.
Conditions
- Psychotic Disorders
- Cannabis Use Disorder
- Cannabis Dependence
- Cannabis Use
- Schizophrenia; Psychosis
- Cognitive Dysfunction
- Memory Impairment
- Neuroimaging
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Contingency management | Contingency management will be used to encourage abstinence |
Timeline
- Start date
- 2022-04-21
- Primary completion
- 2027-05-01
- Completion
- 2027-05-01
- First posted
- 2022-07-06
- Last updated
- 2024-05-03
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT05445180. Inclusion in this directory is not an endorsement.