Nabilone for Cannabis Dependence: A Pilot Study
Information source: Mclean Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cannabis Dependence; Marijuana Dependence
Intervention: Nabilone (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: Mclean Hospital Official(s) and/or principal investigator(s): Kevin P Hill, MD, MHS, Principal Investigator, Affiliation: Mclean Hospital
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.
Clinical Details
Official title: Nabilone for Cannabis Dependence: A Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: change from baseline in cannabis use at 10 weeks
Secondary outcome: change from baseline neuropsychological performance at 4 weekschange from baseline cannabis use at 14 weeks change from baseline in neuropsychological performance at 10 weeks
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
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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 .
Locations and Contacts
McLean Hospital, Belmont, Massachusetts 02478, United States
Additional Information
Starting date: June 2010
Last updated: October 10, 2014
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