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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Mclean Hospital
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Kevin P. Hill, MD, MHS, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01598896
First received: May 11, 2012
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Cannabis Dependence
Marijuana Dependence
Drug: Dronabinol
Drug: Clonidine
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Change from baseline in cannabis use at 10 weeks [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    Self-report and quantitative cannabis urine screens


Secondary Outcome Measures:
  • Change in withdrawal symptoms from baseline at 10 weeks [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    Scores on the Marijuana Withdrawal Checklist (Budney et al. 1999)

  • Change from baseline in cannabis use at 14 weeks [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
    Self-report and quantitative cannabis urine screens

  • Change in withdrawal symptoms from baseline at 14 weeks [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
    Scores on the Marijuana Withdrawal Checklist (Budney et al. 1999)


Estimated Enrollment: 18
Study Start Date: May 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dronabinol
Dronabinol titrated to 5 mg three times daily
Drug: Dronabinol
Dronabinol titrated to 5 mg three times daily
Other Name: Dronabinol (Marinol), CSA Drug Code 7369, Schedule III, NDC 54868-3189-0
Experimental: Clonidine
Clonidine 0.1 mg twice daily
Drug: Clonidine
Clonidine 0.1 mg twice daily
Other Name: Clonidine (Catapres), NDC 16590-266-30
Placebo Comparator: Placebo
Placebo
Drug: Placebo
One placebo capsule by mouth twice daily

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598896

Contacts
Contact: William M Hurley-Welljams-Dorof, BS 617-855-3156 wdorof@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: William M Hurley-Welljams-Dorof, BS    617-855-3156    wdorof@mclean.harvard.edu   
Principal Investigator: Kevin P Hill, MD, MHS         
Sponsors and Collaborators
Mclean Hospital
Brain & Behavior Research Foundation
Investigators
Principal Investigator: Kevin P Hill, MD, MHS Mclean Hospital
  More Information

No publications provided

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
Study First Received: May 11, 2012
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mclean Hospital:
Cannabis Dependence
Marijuana Dependence
Cannabis Use Disorders
Cannabis Withdrawal
Dronabinol
Clonidine
Schizophrenia

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

ClinicalTrials.gov processed this record on October 23, 2014