Medicinal Cannabis for Painful HIV Neuropathy - Full Text View

Sponsor:	Center for Medicinal Cannabis Research
Information provided by:	Center for Medicinal Cannabis Research
ClinicalTrials.gov Identifier:	NCT00255580

Purpose

The purpose of this study is to determine if medicinal cannabis (marijuana) is safe and effective for treating pain in individuals with HIV-associated distal, sensory-predominant polyneuropathy (DSPN).

Condition	Intervention	Phase
Neuropathic Pain	Drug: Smoked cannabis	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Placebo-Controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Marijuana

Drug Information available for: GW-1000 Cannabis

U.S. FDA Resources

Further study details as provided by Center for Medicinal Cannabis Research:

Primary Outcome Measures:

Descriptor Differential Scale (DDS) [ Time Frame: Baseline, Post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in the use of opioid and non-opioid analgesics [ Time Frame: Post-Treatment ] [ Designated as safety issue: No ]
Changes in measures of everyday functioning and subject-perceived quality of life [ Time Frame: Baseline, Post-Treatment ] [ Designated as safety issue: No ]
Adverse effects [ Time Frame: Post-Treatment ] [ Designated as safety issue: Yes ]
Adverse cognitive effects as assessed by neuropsychological testing. [ Time Frame: Baseline, Post-Treatment ] [ Designated as safety issue: Yes ]

Enrollment:	28
Study Start Date:	September 2001
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Active cannabis (1-8% THC by weight)	Drug: Smoked cannabis
Placebo Comparator: 2 Placebo cannabis	Drug: Smoked cannabis

Detailed Description:

Peripheral neuropathy occurs in over 30% of patients with HIV infection, making it among the most common neurological complications of HIV infection. Nucleoside analogues such as ddI and d4T, key components of modern, potent, combination antiretroviral therapies (ART), are also neurotoxic and contribute to the frequent occurence of painful neuropathy. By using treatment with available non-narcotic analgesic and adjunctive pain medications, approximately half of patients with painful HIV neuropathy obtain sufficient pain control.

On the first day each study week (active or placebo), participants will follow a specific titration procedure to achieve the optimal dose. This optimal dose will then be continued for the duration of the treatment week. Participants will undergo a 2-week washout period, after which they crossover to the other arm (active or placebo) and will again repeat the dose titration and dose maintenance procedures.

Comparison: Active cannabis doses ranging from 2-8% THC will be compared to placebo for the reduction of neuropathic pain.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented HIV infection
Meets clinical and electrodiagnostic criteria for HIV-associated DSPN at entry
Daily pain for at least three consecutive months with an average daily pain magnitude score of at least 5 on the Descriptor Differential Scale
Inadequate pain relief with prior treatment for painful HIV neuropathy using drugs from at least two different classes of pain-modifying agents (NSAIDS, low-potency opioids, high-potency opioids, sodium channel blockers, other adjunctive pain treatments)
Age 21-65 years
Stable use of opioid and non-opioid analgesic medications during the two weeks prior to study entry

Exclusion Criteria:

Positive urine toxicology screen for cannabinoids during the "wash-in" week prior to initiating study treatment
Recent (i.e. during the month prior to study entry) history of marijuana use more than twice a week
Previous psychosis with or intolerance to cannabinoids
A lifetime history (ever) of dependence on cannabis
Meeting criteria for alcohol or drug dependence within the last 12 months
Active, major psychiatric disorder likely, in the investigator's opinion, to interfere with adherence to the study protocol
Active AIDS-defining opportunistic disease (a history of AIDS-defining opportunistic disease which is no longer active or progressing will not be grounds for exclusion)
Diabetes mellitus, renal failure with uremia, alcohol abuse, previous spinal surgery, or other documented causes of neuropathy or neuropathic pain
Pulmonary disease of sufficient severity to require the use of supplemental oxygen
Asthma
Life expectancy less than 6 weeks or an active, acute illness likely to interfere with completion of the study protocol
Pregnancy
Failure to use adequate birth control in an individual with reproductive potential
Minority status (less than 21 years), or persons over age 65 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255580

Locations

United States, California
UC San Diego, Hillcrest Medical Center
San Diego, California, United States, 92103

Sponsors and Collaborators

Center for Medicinal Cannabis Research

Investigators

Principal Investigator:

Ronald Ellis, M.D., Ph.D.

University of California, San Diego

More Information

Additional Information:

Center for Medicinal Cannabis Research This link exits the ClinicalTrials.gov site

HIV Neurobehavioral Research Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ronald J. Ellis, M.D., Ph.D., University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00255580 History of Changes
Other Study ID Numbers:	C00-SD-104
Study First Received:	November 17, 2005
Last Updated:	February 20, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Center for Medicinal Cannabis Research:

neuropathy
cannabis
marijuana
HIV
DSPN

Additional relevant MeSH terms:

Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases

Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012