Nabilone for Cannabis Dependence: A Pilot Study

NCT ID: NCT01347762

Last Updated: 2018-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2017-06-09

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.

Conditions

Cannabis Dependence; Marijuana Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nabilone

nabilone titrated to 2 mg daily

Group Type: EXPERIMENTAL

Nabilone

Intervention Type: DRUG

nabilone titrated to 1 mg by mouth twice daily

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

one placebo capsule by mouth twice daily

Interventions

Nabilone

nabilone titrated to 1 mg by mouth twice daily

Intervention Type: DRUG

Placebo

one placebo capsule by mouth twice daily

Intervention Type: DRUG

Other Intervention Names

Nabilone (Cesamet), CSA Drug Code 7379, Schedule II, NDC 0037-1221-50

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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kevin P. Hill, MD, MHS

Psychiatrist-In-Charge

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin P Hill, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K99DA029115-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010-P-000096

Identifier Type: -

Identifier Source: org_study_id