Trial Outcomes & Findings for Cannabis and Schizophrenia: Self-Medication and Agonist Treatment (NCT NCT00946348)

Results Overview

Average Z scores for the region-of-interest functional connectivity at the second scan (when subjects received either a cannabis cigarette or 15mg of dronabinol) between the bilateral nucleus accumbens (NAc) and ventral anterior cingulate cortex (vACC) for patients with schizophrenia and co-occurring cannabis use disorder.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

Measures were acquired at peak THC level for each of the two drugs up to 4 hours.

Results posted on

2021-07-12

Participant Flow

Recruitment was conducted through Dartmouth Hitchcock Medical Center, and local community mental health centers.

Of the 52 people who consented to participate in the study, 12 met eligibility criteria for the main study and were randomized. Because persons who met entry criteria received study treatment on only one day, all randomized participants completed the study.

Participant milestones

Participant milestones
Measure	Dronabinol Dronabinol 15 mg	Cannabis Cannabis cigarette (3.6% THC)
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cannabis and Schizophrenia: Self-Medication and Agonist Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dronabinol n=6 Participants Dronabinol 15 mg	Cannabis n=6 Participants Cannabis cigarette (3.6% THC)	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32.17 years STANDARD_DEVIATION 8.32 • n=5 Participants	36.2 years STANDARD_DEVIATION 9.6 • n=7 Participants	34.2 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Measures were acquired at peak THC level for each of the two drugs up to 4 hours.

Average Z scores for the region-of-interest functional connectivity at the second scan (when subjects received either a cannabis cigarette or 15mg of dronabinol) between the bilateral nucleus accumbens (NAc) and ventral anterior cingulate cortex (vACC) for patients with schizophrenia and co-occurring cannabis use disorder.

Outcome measures

Outcome measures
Measure	Dronabinol n=6 Participants Dronabinol 15 mg	Cannabis n=6 Participants Cannabis cigarette (3.6% THC)
fMRI Connectivity of Regions of Interest (ROI) Within the Brain Reward Circuitry (BRC).	.40 Z score Standard Deviation .85	.33 Z score Standard Deviation .38

SECONDARY outcome

Timeframe: Over 8 hours

Outcome measures

Outcome data not reported

Adverse Events

Dronabinol

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cannabis

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dronabinol n=6 participants at risk Dronabinol 15 mg	Cannabis n=6 participants at risk Cannabis cigarette (3.6% THC)
Psychiatric disorders Cannabis Withdrawal	33.3% 2/6 • Number of events 5 • Adverse events were recorded from the date of consent through the final telephone contact with the patient after the second scan. Though the time differed based on scheduling of patients, it was typically 4-5 weeks.	50.0% 3/6 • Number of events 11 • Adverse events were recorded from the date of consent through the final telephone contact with the patient after the second scan. Though the time differed based on scheduling of patients, it was typically 4-5 weeks.
Psychiatric disorders Anxiety	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the date of consent through the final telephone contact with the patient after the second scan. Though the time differed based on scheduling of patients, it was typically 4-5 weeks.	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the date of consent through the final telephone contact with the patient after the second scan. Though the time differed based on scheduling of patients, it was typically 4-5 weeks.
Psychiatric disorders Increased Psychiatric Symptoms	0.00% 0/6 • Adverse events were recorded from the date of consent through the final telephone contact with the patient after the second scan. Though the time differed based on scheduling of patients, it was typically 4-5 weeks.	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the date of consent through the final telephone contact with the patient after the second scan. Though the time differed based on scheduling of patients, it was typically 4-5 weeks.
Psychiatric disorders Decreased Sleep	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the date of consent through the final telephone contact with the patient after the second scan. Though the time differed based on scheduling of patients, it was typically 4-5 weeks.	0.00% 0/6 • Adverse events were recorded from the date of consent through the final telephone contact with the patient after the second scan. Though the time differed based on scheduling of patients, it was typically 4-5 weeks.
Gastrointestinal disorders Less Appetite	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the date of consent through the final telephone contact with the patient after the second scan. Though the time differed based on scheduling of patients, it was typically 4-5 weeks.	0.00% 0/6 • Adverse events were recorded from the date of consent through the final telephone contact with the patient after the second scan. Though the time differed based on scheduling of patients, it was typically 4-5 weeks.

Additional Information

Alan I. Green, M.D.

Geisel School of Medicine at Dartmouth

Phone: 603-650-7549

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place