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Medicinal Cannabis for Painful HIV Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00255580
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : February 28, 2008
Information provided by:
Center for Medicinal Cannabis Research

Brief Summary:
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 or disease Intervention/treatment Phase
Neuropathic Pain Drug: Smoked cannabis Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-Controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy
Study Start Date : September 2001
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Marijuana

Arm Intervention/treatment
Experimental: 1
Active cannabis (1-8% THC by weight)
Drug: Smoked cannabis
Placebo Comparator: 2
Placebo cannabis
Drug: Smoked cannabis

Primary Outcome Measures :
  1. Descriptor Differential Scale (DDS) [ Time Frame: Baseline, Post-treatment ]

Secondary Outcome Measures :
  1. Changes in the use of opioid and non-opioid analgesics [ Time Frame: Post-Treatment ]
  2. Changes in measures of everyday functioning and subject-perceived quality of life [ Time Frame: Baseline, Post-Treatment ]
  3. Adverse effects [ Time Frame: Post-Treatment ]
  4. Adverse cognitive effects as assessed by neuropsychological testing. [ Time Frame: Baseline, Post-Treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00255580

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United States, California
UC San Diego, Hillcrest Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
Center for Medicinal Cannabis Research
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Principal Investigator: Ronald Ellis, M.D., Ph.D. University of California, San Diego
Additional Information:
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Responsible Party: Ronald J. Ellis, M.D., Ph.D., University of California, San Diego Identifier: NCT00255580    
Other Study ID Numbers: C00-SD-104
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: February 28, 2008
Last Verified: February 2008
Keywords provided by Center for Medicinal Cannabis Research:
Additional relevant MeSH terms:
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Marijuana Abuse
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders