Cannabis for Spasticity in Multiple Sclerosis

NCT ID: NCT00682929

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-14
• Study Completion Date: 2011-08-17

Brief Summary

The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis.

Detailed Description

The treatment of MS is far from satisfactory. For acute attacks, high dose corticosteroids seem to reduce the duration of attacks and to reduce the likelihood of future attacks. Immunomodulatory agents, available in this disease over the last decade, reduce the frequency of severe attacks by about one third. The remainder of the treatments are symptomatic, aimed at reducing the disability already present.

Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may have the potential for affecting both the pathogenic mechanisms and the symptoms of MS. In light of the autoimmune hypothesis of the etiology of MS, THC could directly alter immune function in a manner that might reduce (or increase) the primary pathology of the disease.

Comparisons: Three treatment arms will be compared:

1. inhaled cannabis and oral placebo

2. inhaled placebo and oral THC

3. inhaled placebo and oral placebo

The effects of these agents analyzed at 3 weeks and 7 weeks.

Conditions

Multiple Sclerosis

Study Design

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

Study Groups

1) Inhaled Cannabis

Inhaled cannabis is compared to oral placebo.

Group Type: ACTIVE_COMPARATOR

Inhaled Cannabis

Intervention Type: DRUG

Participants will be instructed to smoke one cannabis cigarette, daily for 7 weeks.

Oral Placebo

Intervention Type: DRUG

Participants will be instructed to take two placebo tablets two hours prior to the inhaled medication, daily for 7 weeks.

2) Oral THC

Inhaled placebo is compared to oral THC.

Group Type: ACTIVE_COMPARATOR

Oral THC

Intervention Type: DRUG

Participants will be instructed to take two 5 mg dronabinol tablets two hours prior to the inhaled medication, daily for 7 weeks.

Inhaled placebo

Intervention Type: DRUG

Participants will be instructed to smoke one placebo cigarette, daily for 7 weeks.

3) Placebo

Inhaled placebo is compared to oral placebo.

Group Type: PLACEBO_COMPARATOR

Oral Placebo

Intervention Type: DRUG

Participants will be instructed to take two placebo tablets two hours prior to the inhaled medication, daily for 7 weeks.

Inhaled placebo

Intervention Type: DRUG

Participants will be instructed to smoke one placebo cigarette, daily for 7 weeks.

Interventions

Inhaled Cannabis

Participants will be instructed to smoke one cannabis cigarette, daily for 7 weeks.

Intervention Type: DRUG

Oral THC

Participants will be instructed to take two 5 mg dronabinol tablets two hours prior to the inhaled medication, daily for 7 weeks.

Intervention Type: DRUG

Oral Placebo

Participants will be instructed to take two placebo tablets two hours prior to the inhaled medication, daily for 7 weeks.

Intervention Type: DRUG

Inhaled placebo

Participants will be instructed to smoke one placebo cigarette, daily for 7 weeks.

Intervention Type: DRUG

Other Intervention Names

Cannabis; dronabinol; placebo; placebo

Eligibility Criteria

Inclusion Criteria

• Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria
• Moderate or severe spasticity
• Age 21 or older
• Must live close to the Sacramento, CA area

Exclusion Criteria

• Preexisting pulmonary conditions, including poorly controlled asthma, chronic bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders
• Preexisting cardiac conditions, including ischemic heart disease, congestive heart failure, and other significant cardiac disorders
• Inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative or hypnotic medications during the duration of the study
• Pre-existing dementia, mania, depression or schizophrenia or other poorly controlled psychiatric illness
• Past history of abuse of recreational drugs, including marijuana and alcohol in the last 12 months
• History of or currently meets DSM-IV criteria for dependence on cannabis
• Use of cannabis, marijuana, or THC in the last four weeks
• Preexisting dementia, mania, depression, or schizophrenia or other poorly controlled psychiatric illness
• Exacerbation of MS within 30 days prior to screening visit
• Current use of cyclophosphamide, mitoxantrone, or cladribine
• Arthritis, bony and soft tissue disorders interfering with spasticity measures
• Inability to provide informed consent
• Recent cannabis use of more than twice per week one month prior to study entry
• For females of child bearing potential, inability to comply with adequate contraception

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Apperson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis Medical Center

Sacramento, California, United States

Countries

United States

Other Identifiers

MS Society Award # RG 3781-A-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

251429

Identifier Type: -

Identifier Source: org_study_id