Cannabis and Schizophrenia: Self-Medication and Agonist Treatment

• ClinicalTrials.gov Identifier: NCT00946348
• Recruitment Status: Completed
• First Posted: July 27, 2009
• Results First Posted: September 29, 2014
• Last Update Posted: March 14, 2018
• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA); Indiana University; Columbia University; University of Vermont; University of Massachusetts, Worcester
• Information provided by (Responsible Party): Alan Green, Dartmouth-Hitchcock Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
• Conditions: Schizophrenia; Dual Diagnosis; Schizoaffective Disorder; Psychotic Disorder; Cannabis Use Disorder
• Interventions: Drug: Dronabinol; Drug: Cannabis
• Enrollment: 12

Participant Flow

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

Arm/Group Title	Dronabinol	Cannabis
Arm/Group Description	Dronabinol 15 mg	Cannabis cigarette (3.6% THC)
Period Title: Overall Study
Started	6	6
Completed	6	6
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Dronabinol	Cannabis	Total
Arm/Group Description		Dronabinol 15 mg	Cannabis cigarette (3.6% THC)	Total of all reporting groups
Overall Number of Baseline Participants		6	6	12
Baseline Analysis Population Description		52 subjects consented; 15 were in a pilot study to determine the dose of dronabinol and strength of the marijuana cigarette and 14 were health controls (who received no drug)for comparison. The remaining 23 subjects consented to the Main Study and 12 were met eligibility criteria and were randomized to receive dronabinol or a marijuana cigarette.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	12 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	6 100.0%	6 100.0%	12 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	6 participants	6 participants	12 participants
		32.17 (8.32)	36.2 (9.6)	34.2 (10.6)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	12 participants
	Female	2 33.3%	1 16.7%	3 25.0%
	Male	4 66.7%	5 83.3%	9 75.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	6 participants	6 participants	12 participants
		6	6	12

Outcome Measures

1. Primary Outcome

Title	fMRI Connectivity of Regions of Interest (ROI) Within the Brain Reward Circuitry (BRC).
Description	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.
Time Frame	Measures were acquired at peak THC level for each of the two drugs up to 4 hours.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dronabinol	Cannabis
Arm/Group Description:	Dronabinol 15 mg	Cannabis cigarette (3.6% THC)
Overall Number of Participants Analyzed	6	6
Mean (Standard Deviation); Unit of Measure: Z score
	.40 (.85)	.33 (.38)

2. Secondary Outcome

Title	To Assess the Effects of Dronabinol in This Population to Determine Whether Measures of Craving, Mood and Negative Symptoms Will Improve Using the PANSS; and to Determine Whether Measures of Psychotic Symptoms and Cognitive Deficits Will Increase.
Description	[Not Specified]
Time Frame	Over 8 hours

Outcome Measure Data Not Reported

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Dronabinol		Cannabis
Arm/Group Description	Dronabinol 15 mg		Cannabis cigarette (3.6% THC)
All-Cause Mortality
	Dronabinol		Cannabis
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Dronabinol		Cannabis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0.00%)		0/6 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Dronabinol		Cannabis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/6 (33.33%)		3/6 (50.00%)
Gastrointestinal disorders
Less Appetite † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Psychiatric disorders
Cannabis Withdrawal † 1 [1]	2/6 (33.33%)	5	3/6 (50.00%)	11
Anxiety † 1	1/6 (16.67%)	1	1/6 (16.67%)	1
Increased Psychiatric Symptoms † 1 [2]	0/6 (0.00%)	0	1/6 (16.67%)	1
Decreased Sleep † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, Source Vocabulary; [1] This was assessed using the Cannabis Withdrawal Assessment Scale at each visit. On any day that a participant scored greater than 12, he or she would be considered to be experiencing cannabis withdrawal.; [2] The actual symptom that increased was not noted but was believed to be secondary to cannabis withdrawal.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Alan I. Green, M.D.
• Organization: Geisel School of Medicine at Dartmouth
• Phone: 603-650-7549
• EMail: alan.i.green@dartmouth.edu

• Responsible Party: Alan Green, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT00946348
• Other Study ID Numbers: R01DA013196 ( U.S. NIH Grant/Contract ); 1R01DA026799-01 ( U.S. NIH Grant/Contract ); R01DA013196 ( U.S. NIH Grant/Contract ); R01DA026799-01 ( U.S. NIH Grant/Contract ); DPMC ( Other Identifier: NIDA )
• First Submitted: July 24, 2009
• First Posted: July 27, 2009
• Results First Submitted: April 9, 2014
• Results First Posted: September 29, 2014
• Last Update Posted: March 14, 2018