Cannabis DependencePhase 2/3DCCSNCT01598896
Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia
A Phase 2/3 study testing Dronabinol and Clonidine in people with Cannabis Dependence and Marijuana Dependence, run by Mclean Hospital at 1 site in United States.
Trial summary
Cannabis use disorders are an important public health problem in the United States, but no effective pharmacotherapies are available to treat these disorders. People with schizophrenia are more likely than healthy people to abuse cannabis. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cannabis Dependence, Marijuana Dependence
- What is being tested?
- Dronabinol and Clonidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Aug 2017
- Phase
- Phase 2/3
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range 18-45 years
- DSM-IV diagnosis of cannabis dependence, based on the Structured Clinical Interview for DSM-IV (SCID)
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder, based on the Structured Clinical Interview for DSM-IV (SCID)
- express a desire to quit cannabis use within the next 30 days
- have used cannabis on ≥20 days within the past 30 days (i.e., an average of ≥5 day per week)
- identify cannabis as their primary drug of abuse; 6) stable on antipsychotic medication for ≥1 month
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- for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests
- consent for us to communicate with their prescribing clinician if one exists
- furnish the names of 2 locators, who would assist study staff in locating them during the study period
- live close enough to McLean Hospital to attend study visits
- plan to stay in the Boston area for the next 3 months
- are willing and able to sign informed consent.
Who cannot join
- Current diagnosis of other drug or alcohol dependence (excluding nicotine)
- significant cardiac disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
- Positive and Negative Syndrome Scale (PANSS) subscale for positive symptoms of psychosis item > 3 (moderate) at baseline evaluation
- current medical condition that could prevent regular study attendance
- liver function tests >3 times the upper limit of normal range
- history of seizure disorder or history of head trauma or CNS insult that could predispose the subject to seizures
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- taking clozapine
- current suicidal risk
- bradycardia less than or equal to 50 bpm, supine blood pressure of less than or equal to 100/65, a seated blood pressure of less than or equal to 90/60, or orthostatic change of >20 systolic or >10 diastolic on standing, at screening or any pre-dose assessment, or symptoms attributable to low BP (i.e. lightheadedness or dizziness on standing)
- mental retardation or organic mental disorder
- currently in a residential treatment setting in which substance use is monitored and restricted, since the restricted access to drugs could represent an important confounding variable
- pregnant, nursing, or, if a woman of childbearing potential, not using a form of birth control judged by the investigator to be effective
- concomitant treatment with opioid analgesics, sedative hypnotics, or other known CNS depressants
- known hypersensitivity to cannabinoids or sesame oil or clonidine
- disease of the gastrointestinal system, liver, or kidneys that may impede metabolism or excretion of dronabinol
- inability to read or write in English that would hinder their ability to follow study procedures
- history of seizures or a family history of seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Cannabis use disorders are an important public health problem in the United States, but no effective pharmacotherapies are available to treat these disorders. People with schizophrenia are more likely than healthy people to abuse cannabis. Cannabis use may worsen clinical outcomes in this group, making the identification of pharmacotherapy to treat cannabis dependence in those with schizophrenia important. The investigators intend to test the combination of dronabinol, a cannabinoid agonist, and the α2-adrenergic agonist clonidine, for cannabis dependence in subjects with schizophrenia. The combination of dronabinol and clonidine may alleviate cannabis withdrawal symptoms while allowing treatment-seeking outpatients to benefit from medical management (MM) sessions when they are trying to stop using cannabis. The investigators propose to assess the relationship of dronabinol and clonidine, when added to MM, on cannabis use patterns in cannabis-dependent patients with schizophrenia.
Hypothesis: The investigators predict that combination pharmacotherapy of dronabinol and clonidine will significantly reduce cannabis use compared to those receiving placebo.
Read the detailed description
Subjects will receive either the combination of dronabinol and clonidine or placebo in addition to medical management (MM) over a 10-week treatment period. Following treatment completion, subjects will have follow-up visits until 14 weeks after treatment initiation. This pilot study will evaluate the feasibility of the combination of dronabinol and clonidine for cannabis dependence and will establish effect sizes for a larger trial.
Cannabis use disorders are highly prevalent in the United States and rising among high school seniors, making the identification of efficacious treatments for cannabis dependence of critical clinical and public health significance. Schizophrenia is overrepresented among those with cannabis dependence. At the completion of this study, the investigators hope to have improved our understanding of the relationship of the pharmacotherapy combination of dronabinol and clondine on cannabis use.
- Conditions
- Cannabis Dependence, Marijuana Dependence
- Being tested
- Dronabinol, Clonidine, Placebo
- Keywords
- Cannabis Dependence, Marijuana Dependence, Cannabis Use Disorders, Cannabis Withdrawal, Dronabinol, Clonidine, Schizophrenia
- Medical subject headings
- Marijuana Abuse, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
Also called Marinol, CSA Drug Code 7369, Schedule III, NDC 54868-3189-0
Dronabinol titrated to 5 mg three times daily
ClonidineDrug
Also called Catapres, NDC 16590-266-30
Clonidine 0.1 mg twice daily
PlaceboDrug
One placebo capsule by mouth twice daily
| Study group | Role | What they receive |
|---|---|---|
| Dronabinol + Clonidine | Experimental | Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily Receives: Drug: Dronabinol; Drug: Clonidine |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Cannabis Use at 10 Weeks
Subject self-report hits of marijuana per day at week 10
Measured: At 10 weeks
Secondary outcomes (3)
Change in Craving Symptoms From Baseline at 10 Weeks
Scores on the Marijuana Craving Questionnaire (MCQ) (Heishman et al. 2009) - The 4 Factor Total Score.
Maximum Score = 84 Minimum Score = 12 The higher the score, the more severe marijuana craving symptoms endorsed by the subject.
Measured: At 10 weeks
Change From Baseline in Cannabis Use at 14 Weeks
Self-report cannabis use at 14 weeks after initiating the study.
Measured: At 14 weeks
Change in Craving Symptoms From Baseline at 14 Weeks
Scores on the Marijuana Craving Questionnaire (Heishman et al. 2009) - The 4 Factor Total Score
Maximum Score = 84 Minimum Score = 12 The higher the score, the more severe marijuana craving symptoms endorsed by the subject.
Measured: At 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: low enrollment due to limited resources
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 Cannabis DependenceStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Principal investigator, Kevin P. Hill, MD, MHS, Mclean Hospital
- Investigators
- Kevin P Hill, MD, MHS, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598896
- Sponsor's protocol ID
- 2010P-002262
- Other IDs
- Brain and Behavior Research
- Acronym
- DCCS
- Status last verified
- Jul 2018
- First submitted
- 11 May 2012
- Last updated
- 29 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01598896
- Acronym / sponsor ID
- DCCS / 2010P-002262
- Conditions
- Cannabis Dependence, Marijuana Dependence
- Keywords
- Cannabis Dependence, Marijuana Dependence, Cannabis Use Disorders, Cannabis Withdrawal, Dronabinol, Clonidine, Schizophrenia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment due to limited resources
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- May 2012
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Posted 1 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cannabis use disorders are an important public health problem in the United States, but no effective pharmacotherapies are available to treat these disorders. People with schizophrenia are more likely than healthy people to abuse cannabis. Cannabis use may worsen clinical outcomes in this group, making the identification of pharmacotherapy to treat cannabis dependence in those with schizophrenia important. The investigators intend to test the combination of dronabinol, a cannabinoid agonist, and the α2-adrenergic agonist clonidine, for cannabis dependence in subjects with schizophrenia. The combination of dronabinol and clonidine may alleviate cannabis withdrawal symptoms while allowing treatment-seeking outpatients to benefit from medical management (MM) sessions when they are trying to stop using cannabis. The investigators propose to assess the relationship of dronabinol and clonidine, when added to MM, on cannabis use patterns in cannabis-dependent patients with schizophrenia.
Hypothesis: The investigators predict that combination pharmacotherapy of dronabinol and clonidine will significantly reduce cannabis use compared to those receiving placebo.
Detailed description
Subjects will receive either the combination of dronabinol and clonidine or placebo in addition to medical management (MM) over a 10-week treatment period. Following treatment completion, subjects will have follow-up visits until 14 weeks after treatment initiation. This pilot study will evaluate the feasibility of the combination of dronabinol and clonidine for cannabis dependence and will establish effect sizes for a larger trial.
Cannabis use disorders are highly prevalent in the United States and rising among high school seniors, making the identification of efficacious treatments for cannabis dependence of critical clinical and public health significance. Schizophrenia is overrepresented among those with cannabis dependence. At the completion of this study, the investigators hope to have improved our understanding of the relationship of the pharmacotherapy combination of dronabinol and clondine on cannabis use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dronabinol + Clonidine | Experimental | Drug: Dronabinol, Drug: ClonidineDronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age range 18-45 years
- DSM-IV diagnosis of cannabis dependence, based on the Structured Clinical Interview for DSM-IV (SCID)
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder, based on the Structured Clinical Interview for DSM-IV (SCID)
- express a desire to quit cannabis use within the next 30 days
- have used cannabis on ≥20 days within the past 30 days (i.e., an average of ≥5 day per week)
Key exclusion criteria (17 listed)
- Current diagnosis of other drug or alcohol dependence (excluding nicotine)
- significant cardiac disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
- Positive and Negative Syndrome Scale (PANSS) subscale for positive symptoms of psychosis item > 3 (moderate) at baseline evaluation
- current medical condition that could prevent regular study attendance
- liver function tests >3 times the upper limit of normal range
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 |
|---|---|---|
| DronabinolAlso: Marinol, CSA Drug Code 7369, Schedule III, NDC 54868-3189-0Dronabinol titrated to 5 mg three times daily | Drug | Dronabinol + Clonidine |
| ClonidineAlso: Catapres, NDC 16590-266-30Clonidine 0.1 mg twice daily | Drug | Dronabinol + Clonidine |
| PlaceboOne placebo capsule by mouth twice daily | Drug | Placebo |
Primary outcome
Change From Baseline in Cannabis Use at 10 Weeks
Time frame: At 10 weeks
Subject self-report hits of marijuana per day at week 10
3 secondary outcomes
Change in Craving Symptoms From Baseline at 10 Weeks
Time frame: At 10 weeks
Change From Baseline in Cannabis Use at 14 Weeks
Time frame: At 14 weeks
Change in Craving Symptoms From Baseline at 14 Weeks
Time frame: At 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- 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.
Kevin P Hill, MD, MHS principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dronabinol and Clonidine in people with Cannabis Dependence and Marijuana Dependence, run by Mclean Hospital at 1 site 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 12 inclusion and 17 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: stopped early, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 1 Aug 2018). 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?
Change From Baseline in Cannabis Use at 10 Weeks (time frame: At 10 weeks). 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 29 Aug 2018.