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

May 30, 2018 updated by: Kevin P. Hill, MD, MHS, Mclean Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
one placebo capsule by mouth twice daily
Experimental: Nabilone
nabilone titrated to 2 mg daily
Drug: Nabilone
nabilone titrated to 1 mg by mouth twice daily
Other Names:
  • Nabilone (Cesamet), CSA Drug Code 7379, Schedule II, NDC 0037-1221-50

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Cannabis Use at 10 Weeks
Time Frame: baseline and 10 weeks
Quantitative cannabis urine screens (THC-COOH:Creatinine ratio)
baseline and 10 weeks
Number of Marijuana Inhales Per Day
Time Frame: Week 10
Average # of marijuana inhales per day during baseline compared to after 10 weeks of treatment.
Week 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Neuropsychological Performance at 4 Weeks
Time Frame: baseline and 4 weeks
performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner
baseline and 4 weeks
Change From Baseline Cannabis Use at 14 Weeks
Time Frame: baseline and 14 weeks
quantitative urine screens - Comparing the THC-COOH to creatinine ratio at baseline and at the end of the study (Week 14)
baseline and 14 weeks
Change From Baseline in Neuropsychological Performance at 10 Weeks
Time Frame: baseline and 10 weeks
performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner
baseline and 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mclean Hospital

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Kevin P Hill, MD, MHS, McLean Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 9, 2017

Study Completion (Actual)

June 9, 2017

Study Registration Dates

First Submitted

April 26, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (Estimate)

May 4, 2011

Study Record Updates

Last Update Posted (Actual)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-P-000096
  • 1K99DA029115-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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