Nabilone for Cannabis Dependence: A Pilot Study (NAB CAN)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kevin P. Hill, MD, MHS, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01347762
First received: April 26, 2011
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

Cannabis use disorders are an important public health problem in the United States, but there are no effective medications available to treat these disorders. The investigators intend to test a medication with interesting properties, nabilone, as a treatment for cannabis dependence and to study the relationship of this treatment with the brain using functional MRI brain scans. Nabilone and marijuana have similar effects upon behaviors and the human body, suggesting that nabilone may decrease cannabis withdrawal symptoms while allowing treatment-seeking patients to benefit from behavioral treatments when they are trying to stop using cannabis. The investigators propose to assess the relationship of nabilone, when added to behavioral treatment, on cannabis use patterns in cannabis-dependent patients. The investigators also aim to determine the effects of nabilone on performance on neuropsychological tests and to assess the correlation of neuropsychological performance to brain changes using functional MRI brain scans. The investigators hypothesize that patients receiving nabilone will reduce their use of cannabis more than patients receiving placebo during this 10-week treatment trial.


Condition Intervention Phase
Cannabis Dependence
Marijuana Dependence
Drug: Nabilone
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: Nabilone for Cannabis Dependence: A Pilot Study

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 from baseline neuropsychological performance at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner

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

  • change from baseline in neuropsychological performance at 10 weeks [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
    performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner


Estimated Enrollment: 16
Study Start Date: June 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nabilone
nabilone titrated to 2 mg daily
Drug: Nabilone
nabilone titrated to 1 mg by mouth twice daily
Other Name: Nabilone (Cesamet), CSA Drug Code 7379, Schedule II, NDC 0037-1221-50
Placebo Comparator: Placebo
Placebo
Drug: Placebo
one placebo capsule by mouth twice daily

Detailed Description:

Cannabis use disorders are an important public health problem in the United States, but no effective pharmacotherapies are available to treat these disorders. The investigators intend to test a novel agonist pharmacotherapy, nabilone, for cannabis dependence and to study the relationship of this treatment with the brain using BOLD fMRI measures. The behavioral and physiological effects of nabilone and Δ9-THC overlap, suggesting that nabilone may ameliorate 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 nabilone, when added to MM, on cannabis use patterns in cannabis-dependent patients. The investigators also aim to determine the effects of nabilone on performance on neuropsychological tests and to assess the correlation of neuropsychological performance to brain changes using BOLD fMRI measures.

In this pilot study, subjects will receive either nabilone or placebo in addition to medical management (MM) over a 10-week treatment period. Subjects' responses to neuropsychological testing carried out while the subject is receiving fMRI scans at 3 time points: at baseline, 4 weeks, and 10 weeks. Following treatment completion, subjects will have a follow-up visit at 14 weeks. This pilot study will evaluate the feasibility of nabilone treatment for cannabis dependence and will establish effect sizes for a larger trial in which subjects will receive high-dose nabilone, low-dose nabilone, or placebo in addition to MM.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age range 18-45 years
  • DSM-IV diagnosis of cannabis dependence, 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 more than4 days within the past 30 days
  • 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
  • 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.

Exclusion Criteria:

  • current diagnosis of other drug or alcohol dependence (excluding nicotine)
  • recent (within 3 months) significant cardiac disease
  • current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder
  • current medical condition (including significant laboratory abnormalities, such as liver function tests >5 times the upper limit of normal range) that could prevent regular study attendance
  • mental retardation or organic mental disorder
  • acutely dangerous or suicidal behavior
  • 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 daily treatment with opioid analgesics, sedative hypnotics, or other known CNS depressants
  • known hypersensitivity to cannabinoids or sesame oil
  • disease of the gastrointestinal system, liver, or kidneys that may impede metabolism or excretion of nabilone
  • inability to read or write in English. The potential hazards of a Schedule II medication like nabilone underscore the importance of English proficiency in this medication trial.
  • unwilling or unable to participate in MRI scanning (e.g., those having pacemakers, bone plates, screws, etc.; claustrophobia)
  • a history of seizures, head trauma or other history of CNS insult that could predispose the subject to 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: NCT01347762

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Kevin P Hill, MD, MHS Mclean Hospital
  More Information

No publications provided

Responsible Party: Kevin P. Hill, MD, MHS, Psychiatrist-In-Charge, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01347762     History of Changes
Other Study ID Numbers: 2010-P-000096, 1K99DA029115-01
Study First Received: April 26, 2011
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mclean Hospital:
cannabis dependence
marijuana dependence
cannabis use disorders
cannabis withdrawal
nabilone

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nabilone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 16, 2014