Effects of Smoked Marijuana on Neuropathic Pain

NCT00254761 | Completed Phase 1 DMC

• 1 other identifier: C02-DA-114
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if smoking marijuana will reduce neuropathic pain without causing too much drowsiness or feeling "too dopey".

Conditions

Neuropathic Pain

Keywords

cannabis; marijuana; neuropathy; antinociception; mood; cognition

Outcome Measures

Primary Outcomes (1)

• Score on a series of pain scales (heat pain threshold, VAS intensity, VAS unpleasantness, pain relief, neuropathic pain scale).

Secondary Outcomes (2)

• Number of subjects who are unable to tolerate the high dose without significant side effects.

• Changes in mood, cognitive impairment, and psychomotor performance (mood - VAS happiness, cognition - Digit Symbol Modalities Test, psychomotor performance - Grooved Pegboard Test).

Study Arms (3)

1

EXPERIMENTAL

High dose cannabis (7.5% THC by weight)

Drug: Cannabis

2

EXPERIMENTAL

Low dose cannabis (3.5% THC by weight)

Drug: Cannabis

3

PLACEBO COMPARATOR

Placebo cannabis

Drug: Cannabis

Interventions

Cannabis DRUG

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand English
• Age greater than 18 and less than 70
• VAS greater than 3/10
• History of previous marijuana use (i.e., avoidance of marijuana naive subjects)
• Negative urine drug screening test
• Nerve Injury a.k.a. Complex Regional Pain Syndrome Type II OR
• Complex Regional Pain Syndrome Type I OR
• Neuropathic pain due to confirmed bilateral distal peripheral neuropathy associated with Diabetes I or II, focal nerve injury, postherpetic neuralgia, spinal cord injury with incomplete myelopathy, central pain following a stroke or focal brain lesion, or clinical definite multiple sclerosis of at least 3 months duration.

You may not qualify if:

• Presence of another painful condition of greater severity than the neuropathic pain condition which is being studied
• Unstable Type 1 or 2 diabetes defined as blood glucose more than 156 mg/dl
• For diabetic subjects maintained on insulin with a stable blood glucose more than 156 mg/dl, a hemoglobin A1C level of more than 0.11 (normal range, 0.048-0.067)
• History of traumatic brain injury
• History of schizophrenia or a past or current history of a serious psychiatric disorder that is currently not well controlled with medications
• Uncontrolled medical condition - coronary artery disease, hypertension, cerebrovascular disease, asthma, TB, COPD, opportunistic infection, malignancy requiring active treatment
• Active substance abuse (alcohol or injection drugs)
• Current use of marijuana (within 30 days of randomization) as determined by urine screening

Sponsors & Collaborators

• Center for Medicinal Cannabis Research: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Links

• Center For Medicinal Cannabis Research

MeSH Terms

Conditions

Neuralgia; Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Barth L Wilsey, M.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 15, 2005
• First Posted: November 17, 2005
• Study Start: November 1, 2003
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: February 28, 2008

Record last verified: 2008-02

Locations

US (1)