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

Primary Purpose

Cannabis Dependence, Marijuana Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nabilone
Placebo
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring cannabis dependence, marijuana dependence, cannabis use disorders, cannabis withdrawal, nabilone

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

  • McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nabilone

Placebo

Arm Description

nabilone titrated to 2 mg daily

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 26, 2011
Last Updated
May 30, 2018
Sponsor
Mclean Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01347762
Brief Title
Nabilone for Cannabis Dependence: A Pilot Study
Acronym
NAB CAN
Official Title
Nabilone for Cannabis Dependence: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 9, 2017 (Actual)
Study Completion Date
June 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence, Marijuana Dependence
Keywords
cannabis dependence, marijuana dependence, cannabis use disorders, cannabis withdrawal, nabilone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nabilone
Arm Type
Experimental
Arm Description
nabilone titrated to 2 mg daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Nabilone
Other Intervention Name(s)
Nabilone (Cesamet), CSA Drug Code 7379, Schedule II, NDC 0037-1221-50
Intervention Description
nabilone titrated to 1 mg by mouth twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
one placebo capsule by mouth twice daily
Primary Outcome Measure Information:
Title
Change From Baseline in Cannabis Use at 10 Weeks
Description
Quantitative cannabis urine screens (THC-COOH:Creatinine ratio)
Time Frame
baseline and 10 weeks
Title
Number of Marijuana Inhales Per Day
Description
Average # of marijuana inhales per day during baseline compared to after 10 weeks of treatment.
Time Frame
Week 10
Secondary Outcome Measure Information:
Title
Change From Baseline Neuropsychological Performance at 4 Weeks
Description
performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner
Time Frame
baseline and 4 weeks
Title
Change From Baseline Cannabis Use at 14 Weeks
Description
quantitative urine screens - Comparing the THC-COOH to creatinine ratio at baseline and at the end of the study (Week 14)
Time Frame
baseline and 14 weeks
Title
Change From Baseline in Neuropsychological Performance at 10 Weeks
Description
performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner
Time Frame
baseline and 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin P Hill, MD, MHS
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

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Nabilone for Cannabis Dependence: A Pilot Study

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