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Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia (DCCS)

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ClinicalTrials.gov Identifier: NCT01598896
Recruitment Status : Terminated (low enrollment due to limited resources)
First Posted : May 15, 2012
Results First Posted : August 1, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Kevin P. Hill, MD, MHS, Mclean Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Cannabis Dependence Marijuana Dependence Drug: Dronabinol Drug: Clonidine Drug: Placebo Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia
Study Start Date : May 2012
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dronabinol + Clonidine
Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily
Drug: Dronabinol
Dronabinol titrated to 5 mg three times daily
Other Name: Marinol, CSA Drug Code 7369, Schedule III, NDC 54868-3189-0

Drug: Clonidine
Clonidine 0.1 mg twice daily
Other Name: Catapres, NDC 16590-266-30

Placebo Comparator: Placebo
Placebo
Drug: Placebo
One placebo capsule by mouth twice daily




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in Craving Symptoms From Baseline at 10 Weeks [ Time Frame: 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.


  2. Change From Baseline in Cannabis Use at 14 Weeks [ Time Frame: At 14 weeks ]
    Self-report cannabis use at 14 weeks after initiating the study.

  3. Change in Craving Symptoms From Baseline at 14 Weeks [ Time Frame: 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.




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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age range 18-45 years
  2. DSM-IV diagnosis of cannabis dependence, based on the Structured Clinical Interview for DSM-IV (SCID)
  3. DSM-IV diagnosis of schizophrenia or schizoaffective disorder, based on the Structured Clinical Interview for DSM-IV (SCID)
  4. express a desire to quit cannabis use within the next 30 days
  5. have used cannabis on ≥20 days within the past 30 days (i.e., an average of ≥5 day per week)
  6. identify cannabis as their primary drug of abuse; 6) stable on antipsychotic medication for ≥1 month
  7. for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests
  8. consent for us to communicate with their prescribing clinician if one exists
  9. furnish the names of 2 locators, who would assist study staff in locating them during the study period
  10. live close enough to McLean Hospital to attend study visits
  11. plan to stay in the Boston area for the next 3 months
  12. are willing and able to sign informed consent.

Exclusion Criteria:

  1. Current diagnosis of other drug or alcohol dependence (excluding nicotine)
  2. significant cardiac disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
  3. Positive and Negative Syndrome Scale (PANSS) subscale for positive symptoms of psychosis item > 3 (moderate) at baseline evaluation
  4. current medical condition that could prevent regular study attendance
  5. liver function tests >3 times the upper limit of normal range
  6. history of seizure disorder or history of head trauma or CNS insult that could predispose the subject to seizures
  7. taking clozapine
  8. current suicidal risk
  9. 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)
  10. mental retardation or organic mental disorder
  11. 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
  12. pregnant, nursing, or, if a woman of childbearing potential, not using a form of birth control judged by the investigator to be effective
  13. concomitant treatment with opioid analgesics, sedative hypnotics, or other known CNS depressants
  14. known hypersensitivity to cannabinoids or sesame oil or clonidine
  15. disease of the gastrointestinal system, liver, or kidneys that may impede metabolism or excretion of dronabinol
  16. inability to read or write in English that would hinder their ability to follow study procedures
  17. history of seizures or a family history of seizures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598896


Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Brain & Behavior Research Foundation
Investigators
Principal Investigator: Kevin P Hill, MD, MHS Mclean Hospital
  Study Documents (Full-Text)

Documents provided by Kevin P. Hill, MD, MHS, Mclean Hospital:

Responsible Party: Kevin P. Hill, MD, MHS, Instructor in Psychiatry, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01598896     History of Changes
Other Study ID Numbers: 2010P-002262
Brain and Behavior Research ( Other Identifier: Brain and Behavior Research Foundation )
First Posted: May 15, 2012    Key Record Dates
Results First Posted: August 1, 2018
Last Update Posted: August 29, 2018
Last Verified: July 2018

Keywords provided by Kevin P. Hill, MD, MHS, Mclean Hospital:
Cannabis Dependence
Marijuana Dependence
Cannabis Use Disorders
Cannabis Withdrawal
Dronabinol
Clonidine
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Marijuana Abuse
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Clonidine
Dronabinol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists