Trial · NCT01964404

Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?

NCT01964404, Phase 1, Completed, Dartmouth-Hitchcock Medical Center; results first posted 2025-12-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment? Trials, record NCT01964404. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01964404

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?
NCT number: NCT01964404
Status: Completed
Phases: Phase 1
Enrollment: 263 participants, actual
Lead sponsor: Dartmouth-Hitchcock Medical Center
Conditions: Schizophrenia, Dual Diagnosis, Psychotic Disorder, Cannabis Use Disorder
Interventions: Marijuana, Dronabinol, Placebo
First posted: 2013-10-17
Last updated: 2025-12-09
Results first posted: 2025-12-09

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Brain Reward Circuit Activation on fMRI Scan	3 hours	Activation of the Brain Reward Circuit (particularly the nucleus accumbens) in anticipation of monetary reward. The 'Measure' is a mean of the Fisher-Z transform of the inter-regional correlation measured for each participant between the nucleus accumbens and anterior cingulate cortex. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences. A Fisher-Z transform of '0' represents a value of '0' for the estimated correlation, which represents no correlation in the activity time series between the regions. The values reflect strengths of functional connectivity between brain regions that can be compared between groups (e.g. Healthy controls and SCZ-CUD groups who received different study drugs). Means and standard deviations similar to healthy controls would be considered a good outcome.
Primary	Resting State Connectivity Within the Brain Reward Circuitry	1 hour after smoking study drug, 3 hours after oral dronabinol	Resting state connectivity within brain reward circuitry as measured with the Fisher-transformed r value of the connectivity maps between the nucleus accumbans and other brain areas. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences (smoked THC vs placebo; oral dronabinol vs placebo)
Secondary	PANSS Positive Symptoms	3 hours after oral THC/placebo	Positive and Negative Symptom Scale (PANSS) Positive Symptom Mean Subscale Score at 2nd Assessment Day, range 7-49, higher = more symptoms. The outcome measure was recorded at single time of measurement. The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Secondary	PANSS Negative Symptoms	3 hours after oral THC/placebo	Positive and Negative Symptom Scale Negative Symptom Mean Subscale Score at 2nd Assessment Day, range 7-49, higher = more symptoms. The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Secondary	Cognitive Functioning, Verbal Learning	4 hours after oral drug	Cognitive functioning, verbal learning Hopkins Verbal Learning Test (HVLT-R) total raw score. Possible range of scores is 0-35, higher is better functioning. The time frame includes 4 hours after oral THC/placebo and 2 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Secondary	Drug Experience, Anxiety	3 hours after taking oral drug	Drug experience ratings of mood and desirability, anxiety rating on a scale of 0-100, higher means more anxiety. The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Secondary	Drug Experience Ratings of Drug Liking	3 hours after taking oral drug	Drug experience ratings of liking rating on a scale of 0-100, higher number = more liking The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Secondary	Cognitive Function, CPT-IP 2 Digit	4 hours after oral drug	Cognitive function, CPT-IP 2 digit measure of Attention. The Continuous Performance Test-Identical Pairs version (CPT-IP)80 assessed attention with range of 1-5, hirer scores indicating better function The outcome measure was recorded at single time of measurement. The time frame includes 4 hours after oral THC/placebo and 2 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Brain Reward Circuit Activation on fMRI Scan	3 hours		z-score	MEAN
PRIMARY	Resting State Connectivity Within the Brain Reward Circuitry	1 hour after smoking study drug, 3 hours after oral dronabinol	Data was collected but cannot be compiled and analysis could not be completed due to death of PI and resulting limited resources for scan data compilation and analyses. There are no immediate resources for analysis in the future.
SECONDARY	PANSS Positive Symptoms	3 hours after oral THC/placebo	Only participants with Schizophrenia were assessed using the Positive and Negative Symptom Scale, as specified in the Study Protocol	score on a scale	MEAN
SECONDARY	PANSS Negative Symptoms	3 hours after oral THC/placebo	This analysis tested whether the marijuana cigarette group had different PANSS negative symptom scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.). Only participants with Schizophrenia were assessed using the Positive and Negative Symptom Scale, as specified in the Study Protocol.	score on a scale	MEAN
SECONDARY	Cognitive Functioning, Verbal Learning	4 hours after oral drug		score on a scale	MEAN
SECONDARY	Drug Experience, Anxiety	3 hours after taking oral drug	Only participants with Schizophrenia and CUD who were given study drug were analyzed for drug experiences, as specified in the Study Protocol	units on a scale	MEAN
SECONDARY	Drug Experience Ratings of Drug Liking	3 hours after taking oral drug	Only participants with Schizophrenia and CUD who were given study drug were analyzed for drug experiences, as specified in the Study Protocol	units on a scale	MEAN
SECONDARY	Cognitive Function, CPT-IP 2 Digit	4 hours after oral drug		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group39

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Brain Reward Circuit Activation on fMRI Scan	Marijuana cigarette and placebo capsule SCZ-CUD	0.05	Standard Deviation 0.098	z-score
Brain Reward Circuit Activation on fMRI Scan	Dronabinol and placebo cigarette. SCZ-CUD	0.14	Standard Deviation 0.076	z-score
Brain Reward Circuit Activation on fMRI Scan	Placebo cigarette and placebo capsule. SCZ-CUD	0.18	Standard Deviation 0.127	z-score
Brain Reward Circuit Activation on fMRI Scan	Marijuana cigarette and placebo capsule CUD only	0.12	Standard Deviation 0.058	z-score
Brain Reward Circuit Activation on fMRI Scan	Dronabinol and placebo cigarette CUD only	0.10	Standard Deviation 0.087	z-score
Brain Reward Circuit Activation on fMRI Scan	Placebo cigarette and placebo capsule. CUD only	0.11	Standard Deviation 0.081	z-score
Brain Reward Circuit Activation on fMRI Scan	SCZ only	0.17	Standard Deviation 0.094	z-score
Brain Reward Circuit Activation on fMRI Scan	Healthy Controls	0.17	Standard Deviation 0.121	z-score
PANSS Positive Symptoms	Marijuana cigarette and placebo capsule SCZ-CUD	11.0	Standard Error 0.54	score on a scale
PANSS Positive Symptoms	Dronabinol and placebo cigarette. SCZ-CUD	9.3	Standard Error 0.40	score on a scale

1 to 10 of 39Source ClinicalTrials.gov

See all 39 results by group

Participant flow80

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Pre-Randomization - Scan 1	STARTED	Cannabis Use Disorder	111
Pre-Randomization - Scan 1	STARTED	Dual Diagnosis (Schizophrenia and Cannabis Use Disorder)	79
Pre-Randomization - Scan 1	STARTED	Schizophrenia	33
Pre-Randomization - Scan 1	STARTED	Healthy Controls	40
Pre-Randomization - Scan 1	STARTED	Marijuana Cigarette and Placebo Capsule CUD Only	0
Pre-Randomization - Scan 1	STARTED	Dronabinol and Placebo Cigarette CUD Only	0
Pre-Randomization - Scan 1	STARTED	Placebo Cigarette and Placebo Capsule CUD Only	0
Pre-Randomization - Scan 1	STARTED	Marijuana Cigarette and Placebo Capsule - SCZ-CUD	0
Pre-Randomization - Scan 1	STARTED	Dronabinol and Placebo Cigarette - SCZ-CUD	0
Pre-Randomization - Scan 1	STARTED	Placebo Cigarette and Placebo Capsule - SCZ-CUD	0

1 to 10 of 80Source ClinicalTrials.gov

See all 80 participant flow

Adverse events444

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anxiety	Psychiatric disorders	Marijuana cigarette and placebo capsule SCZ-CUD	3	11	3
other	Anxiety	Psychiatric disorders	Dronabinol and placebo cigarette SCZ-CUD	2	12	2
other	Anxiety	Psychiatric disorders	Placebo cigarette and placebo capsule. SCZ-CUD	2	11	2
other	Anxiety	Psychiatric disorders	SCZ-CUD not randomized	0	8	0
other	Anxiety	Psychiatric disorders	Marijuana cigarette and placebo capsule CUD only	4	17	4
other	Anxiety	Psychiatric disorders	Dronabinol and placebo cigarette CUD only	2	17	3
other	Anxiety	Psychiatric disorders	Placebo cigarette and placebo capsule CUD only	1	17	1
other	Anxiety	Psychiatric disorders	Cannabis Use Disorder - CUD Did not randomize	1	10	1
other	Anxiety	Psychiatric disorders	SCZ only	1	18	1
other	Anxiety	Psychiatric disorders	SCZ only - Did not complete Scan 2	1	3	1

1 to 10 of 444Source ClinicalTrials.gov

See all 444 adverse events

Adverse event totals36

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Marijuana cigarette and placebo capsule SCZ-CUD	11
Total, all-cause mortality	Dronabinol and placebo cigarette SCZ-CUD	12
Total, all-cause mortality	Placebo cigarette and placebo capsule. SCZ-CUD	11
Total, all-cause mortality	SCZ-CUD not randomized	8
Total, all-cause mortality	Marijuana cigarette and placebo capsule CUD only	17
Total, all-cause mortality	Dronabinol and placebo cigarette CUD only	17
Total, all-cause mortality	Placebo cigarette and placebo capsule CUD only	17
Total, all-cause mortality	Cannabis Use Disorder - CUD Did not randomize	10
Total, all-cause mortality	SCZ only	18
Total, all-cause mortality	SCZ only - Did not complete Scan 2	3

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DA034699	Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?	BRUNETTE, MARY FRANCES	DARTMOUTH-HITCHCOCK CLINIC	NATIONAL INSTITUTE ON DRUG ABUSE	2013 to 2019

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Continuous Performance Test	Secondary outcome	ConductCognition
Verbal Learning	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01964404

GET https://conductscience.org/api/trials/v1/NCT01964404/results?page=2

API reference For AI assistants