Early Phase 1
N=66
Neural Mechanisms of Cannabinoid-impaired Decision-Making in Emerging Adults
Neurosciences · Substance-Related Disorders · Behavior Problem
Bottom Line
View on ClinicalTrials.gov: NCT03944954 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Alpha Learning Rate — .62; .43; .55; .21 Alpha Coefficient
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Placebo TMS Sham (Device); Marinol 10Mg Capsule TMS Sham (Drug); Marinol 30Mg Capsule TMS Sham (Drug); Placebo TMS Real (Device); Marinol 10Mg Capsule TMS Real (Other); Marinol 30Mg Capsule TMS Real (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Michael J. Wesley, PhD
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alpha Learning Rate |
.62; .43; .55; .21; .71; .53 | — |
| PRIMARY Self-Report Subjective "High" |
2.9; 0; 13.8; 3.8; 24.6; 5 | — |
| PRIMARY Elasticity of Demand |
.005; .004; .006; .007; .005; .003 | — |
| PRIMARY Working Memory Performance |
98.0; 96.3; 93.0; 90; 90.1; 86.3 | — |
Summary
Emerging adults are a particularly vulnerable group for experiencing the immediate and potentially lifelong negative impacts of habitual cannabis use, and trends suggest that cannabis use disorder (CUD) will soon escalate in this population. The proposed research will combine clinical pharmacology, non-invasive brain stimulation, and neuroimaging techniques to establish the brain mechanisms of cannabinoid-impaired decision-making processes in emerging adults with CUD. Results from this project will inform CUD prevention/treatment efforts in this high-risk group and address a growing public health concern.
Eligibility Criteria
Inclusion Criteria
- Habitual cannabis use problems
- Body Mass Index ≤30
Exclusion Criteria
- Past or current serious physical or mental health
- Sesame seed oil allergy
- Irregular health issues identified by the Study Physician
- Standard magnetic resonance imaging and transcranial magnetic stimulation exclusion criteria (e.g., metal implants, history of epilepsy, etc.)
- Lack of affective form of birth control (females)
- Pregnancy (females)
Data sourced from ClinicalTrials.gov (NCT03944954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.