Medicinal Cannabis for Painful HIV Neuropathy

February 20, 2008 updated by: Center for Medicinal Cannabis Research

Placebo-Controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Active cannabis (1-8% THC by weight)
Drug: Smoked cannabis
PLACEBO_COMPARATOR: 2
Placebo cannabis
Drug: Smoked cannabis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Descriptor Differential Scale (DDS)
Time Frame: Baseline, Post-treatment
Baseline, Post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in the use of opioid and non-opioid analgesics
Time Frame: Post-Treatment
Post-Treatment
Changes in measures of everyday functioning and subject-perceived quality of life
Time Frame: Baseline, Post-Treatment
Baseline, Post-Treatment
Adverse effects
Time Frame: Post-Treatment
Post-Treatment
Adverse cognitive effects as assessed by neuropsychological testing.
Time Frame: Baseline, Post-Treatment
Baseline, Post-Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Medicinal Cannabis Research

Investigators

  • Principal Investigator: Ronald Ellis, M.D., Ph.D., University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (ACTUAL)

November 1, 2006

Study Completion (ACTUAL)

November 1, 2006

Study Registration Dates

First Submitted

November 17, 2005

First Submitted That Met QC Criteria

November 17, 2005

First Posted (ESTIMATE)

November 21, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 28, 2008

Last Update Submitted That Met QC Criteria

February 20, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C00-SD-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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