SchizophreniaPhase 1NCT01964404
Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?
A Phase 1 study testing Marijuana and Dronabinol in people with Schizophrenia and Dual Diagnosis, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
In this translational research proposal, based on our formulation, we seek to confirm and expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will in fact ameliorate the… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Dual Diagnosis, Psychotic Disorder
- What is being tested?
- Marijuana and Dronabinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to 18 Sep 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Groups 1-3 Participants with schizophrenia and a cannabis use disorder
- Ages 18 - 55 years
- Diagnosis of schizophrenia
- Diagnosis of cannabis abuse or dependence
- Use of cannabis within the month prior to screening
- Willing to remain abstinent for the 14 days before the baseline assessments and throughout the two scans.
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- Psychiatrically stable
- Treated with a stable dose of an antipsychotic medication (except clozapine) for the past month
- Not seeking treatment for their cannabis use disorder.
- Group 4 - Control participants with schizophrenia
- Ages 18 - 55 years
- Diagnosis of schizophrenia
- Willing to remain abstinent as described above
- Psychiatrically stable
- Treated with a stable dose of an antipsychotic medication (except clozapine) for the past month
- Groups 5-7 - Control participants with cannabis use disorder
- Ages 18 - 55 years
- Diagnosis of cannabis abuse or dependence
- Use of cannabis within the month prior to screening
- Willing to remain abstinent as described above
- Not seeking treatment for their cannabis use disorder.
- Group 8 - Healthy control participants
- Ages 18 - 55 years
- Willing to remain abstinent as described above
Who cannot join
- Groups 1-3 with schizophrenia and a cannabis use disorder
- Positive symptoms of psychosis (> 4 [moderate]) on any item of the Positive and Negative Syndrome Scale psychosis subscale (once abstinent) except for the hallucination item. We will exclude for a rating > 5 for this item.
- Cocaine/stimulant use disorder
- Pharmacological treatment for addiction
- Mental retardation
- History of head injury
Show all 42Show fewer
- Metal objects within the body that would contraindicate and MRI
- Pregnancy or currently nursing
- Uncontrolled medical condition
- Taking clozapine
- Any condition that would contraindicate use of cannabis or dronabinol.
- History of a seizure disorder
- Group 4 - Control participants with schizophrenia
- Positive symptoms of psychosis (> 4 [moderate]) on any item of the Positive and Negative Syndrome Scale psychosis subscale (once abstinent) except for the hallucination item. We will exclude for a rating > 5 for this item.
- Any history of a substance use disorder other than nicotine
- Pharmacological treatment for addiction
- Mental retardation
- History of head injury
- Metal objects within the body that would contraindicate and MRI
- Pregnancy or currently nursing
- Uncontrolled medical condition
- Taking clozapine
- Groups 5-7 - Control participants with cannabis use disorder
- Axis I psychiatric diagnosis other than a cannabis use disorder
- Taking any psychotropic medication
- Pharmacological treatment for addiction
- Mental retardation
- History of head injury
- Metal objects within the body that would contraindicate and MRI
- Pregnancy or currently nursing
- Uncontrolled medical condition
- History of a seizure disorder
- Group 8 - Healthy control participants
- Any Axis I psychiatric diagnosis
- Taking any psychotropic medication
- Pharmacological treatment for addiction
- Mental retardation
- History of head injury
- Metal objects within the body that would contraindicate and MRI
- Pregnancy or currently nursing
- Uncontrolled medical condition
- Current tobacco smokers
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Vermont
Burlington, Vermont, 05401
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
In this translational research proposal, based on our formulation, we seek to confirm and expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in these patients and, thereby, provide evidence in support of the role of cannabis as a "self-medication" agent for them.
Read the detailed description
Substance use disorders are strikingly common in patients with schizophrenia and contribute to its morbidity and cost to society. We have proposed a neurobiological formulation suggesting that cannabis and other substance use in these patients may ameliorate a dysfunction in the brain reward circuit(thus serving a "self-medication" function), while also worsening the symptoms and course of schizophrenia.
In this translational research proposal, based on our formulation, we seek to confirm and expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in these patients and, thereby, provide evidence in support of the role of cannabis as a "self-medication" agent for them. Also, by also testing the full range of effects produced by dronabinol (effects on brain reward circuitry assessed with task-based function MRI and resting state connectivity), as well as on reward responsiveness, mood, craving, cognition, psychiatric and extrapyramidal symptoms), we will provide clues as to whether dronabinol should be tried in low doses as an adjunctive agent (with an antipsychotic medication) to limit cannabis use in patients with schizophrenia.
This study will involve 8 groups of 25 participants each. Groups 1-3 will have diagnoses of schizophrenia and cannabis use disorder; Group 4 will have schizophrenia only, Groups 5-7 will have cannabis use disorder only and Group 8 will be healthy control participants. Following screening and baseline neuropsychiatric testing, participants will have two tests days (T1 and T2) that will include task-based functional MRI, including assessment of resting state connectivity, and measuring a number of other parameters including reward responsiveness, mood, craving, symptoms and cognition. The assessments at T1 will be virtually the same for all groups. At T2 Groups 1-3, and Groups 5-7 will be randomly assigned to one of the following conditions prior to the assessments: receiving 15mg of dronabinol and smoking a placebo marijuana cigarette, receiving a placebo pill and smoking a real marijuana cigarette, or receiving a placebo pill and smoking a placebo marijuana cigarette. Group 4 and Group 8 will receive no drug or placebo at T2. Participants receiving drug will have safety assessments before the drug is administered, after the drug is administered but before leaving the research clinic for the day, and again a week later.
- Being tested
- Marijuana, Dronabinol, Placebo
- Keywords
- Dronabinol, Schizophrenia, Dual Diagnosis, Substance Abuse, Cannabis Use Disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarijuanaDrug
Also called Cannabis
Smoked plant with THC
DronabinolDrug
Also called Marinol
Capsule with THC
PlaceboDrug
Capsule with no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Marijuana cigarette and placebo capsule | Experimental | 3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI. Receives: Drug: Marijuana |
| Dronabinol and placebo cigarette | Experimental | Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI. Receives: Drug: Dronabinol |
| Placebo cigarette and placebo capsule | Placebo comparator | Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Reward Circuit Activation on fMRI Scan
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.
Measured: 3 hours
Resting State Connectivity Within the Brain Reward Circuitry
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)
Measured: 1 hour after smoking study drug, 3 hours after oral dronabinol
Secondary outcomes (6)
PANSS Positive Symptoms
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.
Measured: 3 hours after oral THC/placebo
PANSS Negative Symptoms
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.
Measured: 3 hours after oral THC/placebo
Cognitive Functioning, Verbal Learning
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.
Measured: 4 hours after oral drug
Drug Experience, Anxiety
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.
Measured: 3 hours after taking oral drug
Drug Experience Ratings of Drug Liking
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.
Measured: 3 hours after taking oral drug
Cognitive Function, CPT-IP 2 Digit
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.
Measured: 4 hours after oral drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startJul 2014
- Primary completion18 Sep 2021
- Study completion18 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Harvard Medical School (HMS and HSDM), Massachusetts Institute of Technology, Massachusetts General Hospital, Nathan Kline Institute for Psychiatric Research, University of Vermont, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mary F. Brunette, MD, Dartmouth-Hitchcock Medical Center
- Investigators
- Mary F Brunette, MD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964404
- Sponsor's protocol ID
- D14061
- Other IDs
- 1R01DA034699-01A1
- Status last verified
- Oct 2025
- First submitted
- 15 Oct 2013
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?
- ClinicalTrials.gov ID
- NCT01964404
- Acronym / sponsor ID
- D14061
- Keywords
- Dronabinol, Schizophrenia, Dual Diagnosis, Substance Abuse, Cannabis Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Columbia University, Harvard Medical School (HMS and HSDM), Massachusetts Institute of Technology, Massachusetts General Hospital, Nathan Kline Institute for Psychiatric Research, University of Vermont, National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2014
- Primary completion
- 18 Sep 2021 (actual)
- Study completion
- 18 Sep 2021 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Posted 9 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this translational research proposal, based on our formulation, we seek to confirm and expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in these patients and, thereby, provide evidence in support of the role of cannabis as a "self-medication" agent for them.
Detailed description
Substance use disorders are strikingly common in patients with schizophrenia and contribute to its morbidity and cost to society. We have proposed a neurobiological formulation suggesting that cannabis and other substance use in these patients may ameliorate a dysfunction in the brain reward circuit(thus serving a "self-medication" function), while also worsening the symptoms and course of schizophrenia.
In this translational research proposal, based on our formulation, we seek to confirm and expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in these patients and, thereby, provide evidence in support of the role of cannabis as a "self-medication" agent for them. Also, by also testing the full range of effects produced by dronabinol (effects on brain reward circuitry assessed with task-based function MRI and resting state connectivity), as well as on reward responsiveness, mood, craving, cognition, psychiatric and extrapyramidal symptoms), we will provide clues as to whether dronabinol should be tried in low doses as an adjunctive agent (with an antipsychotic medication) to limit cannabis use in patients with schizophrenia.
This study will involve 8 groups of 25 participants each. Groups 1-3 will have diagnoses of schizophrenia and cannabis use disorder; Group 4 will have schizophrenia only, Groups 5-7 will have cannabis use disorder only and Group 8 will be healthy control participants. Following screening and baseline neuropsychiatric testing, participants will have two tests days (T1 and T2) that will include task-based functional MRI, including assessment of resting state connectivity, and measuring a number of other parameters including reward responsiveness, mood, craving, symptoms and cognition. The assessments at T1 will be virtually the same for all groups. At T2 Groups 1-3, and Groups 5-7 will be randomly assigned to one of the following conditions prior to the assessments: receiving 15mg of dronabinol and smoking a placebo marijuana cigarette, receiving a placebo pill and smoking a real marijuana cigarette, or receiving a placebo pill and smoking a placebo marijuana cigarette. Group 4 and Group 8 will receive no drug or placebo at T2. Participants receiving drug will have safety assessments before the drug is administered, after the drug is administered but before leaving the research clinic for the day, and again a week later.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Marijuana cigarette and placebo capsule | Experimental | Drug: Marijuana3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI. |
| Dronabinol and placebo cigarette | Experimental | Drug: DronabinolDronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI. |
| Placebo cigarette and placebo capsule | Placebo comparator | Drug: PlaceboPlacebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Groups 1-3 Participants with schizophrenia and a cannabis use disorder
- Ages 18 - 55 years
- Diagnosis of schizophrenia
- Diagnosis of cannabis abuse or dependence
- Use of cannabis within the month prior to screening
Key exclusion criteria (42 listed)
- Groups 1-3 with schizophrenia and a cannabis use disorder
- Positive symptoms of psychosis (> 4 [moderate]) on any item of the Positive and Negative Syndrome Scale psychosis subscale (once abstinent) except for the hallucination item. We will exclude for a rating > 5 for this item.
- Cocaine/stimulant use disorder
- Pharmacological treatment for addiction
- Mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MarijuanaAlso: CannabisSmoked plant with THC | Drug | Marijuana cigarette and placebo capsule |
| DronabinolAlso: MarinolCapsule with THC | Drug | Dronabinol and placebo cigarette |
| PlaceboCapsule with no active ingredient | Drug | Placebo cigarette and placebo capsule |
Primary outcome
Brain Reward Circuit Activation on fMRI Scan
Time frame: 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.
Resting State Connectivity Within the Brain Reward Circuitry
Time frame: 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)
6 secondary outcomes
PANSS Positive Symptoms
Time frame: 3 hours after oral THC/placebo
PANSS Negative Symptoms
Time frame: 3 hours after oral THC/placebo
Cognitive Functioning, Verbal Learning
Time frame: 4 hours after oral drug
Drug Experience, Anxiety
Time frame: 3 hours after taking oral drug
Drug Experience Ratings of Drug Liking
Time frame: 3 hours after taking oral drug
Cognitive Function, CPT-IP 2 Digit
Time frame: 4 hours after oral drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary F Brunette, MD principal investigator
Dartmouth College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Marijuana and Dronabinol in people with Schizophrenia and Dual Diagnosis, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Reward Circuit Activation on fMRI Scan (time frame: 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.