Nabilone for Cannabis Dependence: A Pilot Study

NCT01347762 | Completed Phase 2 Results

• 2 other identifiers: 2010-P-0000961K99DA029115-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Dependence; Marijuana Dependence

Keywords

cannabis dependence; marijuana dependence; cannabis use disorders; cannabis withdrawal; nabilone

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Cannabis Use at 10 Weeks

  Quantitative cannabis urine screens (THC-COOH:Creatinine ratio)

  baseline and 10 weeks

• Number of Marijuana Inhales Per Day

  Average # of marijuana inhales per day during baseline compared to after 10 weeks of treatment.

  Week 10

Secondary Outcomes (3)

• Change From Baseline Neuropsychological Performance at 4 Weeks

  baseline and 4 weeks

• Change From Baseline Cannabis Use at 14 Weeks

  baseline and 14 weeks

• Change From Baseline in Neuropsychological Performance at 10 Weeks

  baseline and 10 weeks

Study Arms (2)

Nabilone

EXPERIMENTAL

nabilone titrated to 2 mg daily

Drug: Nabilone

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Nabilone DRUG

nabilone titrated to 1 mg by mouth twice daily

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

Nabilone

Placebo DRUG

one placebo capsule by mouth twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabilone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Kevin P. Hill, M.D., M.H.S., Principal Investigator
• Organization: Beth Israel Deaconess Medical Center

khill1@bidmc.harvard.edu

617 667 1597

Study Officials

• Kevin P Hill, MD, MHS

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist-In-Charge

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: May 4, 2011
• Study Start: June 1, 2010
• Primary Completion: June 9, 2017
• Study Completion: June 9, 2017
• Last Updated: June 1, 2018
• Results First Posted: June 1, 2018

Record last verified: 2018-05

Locations

US (1)