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Medicinal Cannabis for Painful HIV Neuropathy

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Smoked cannabis
Sponsored by
Center for Medicinal Cannabis Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring neuropathy, cannabis, marijuana, HIV, DSPN

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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study protocol Active AIDS-defining opportunistic disease (a history of AIDS-defining opportunistic disease which is no longer active or progressing will not be grounds for exclusion) Diabetes mellitus, renal failure with uremia, alcohol abuse, previous spinal surgery, or other documented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

Sites / Locations

  • UC San Diego, Hillcrest Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Active cannabis (1-8% THC by weight)

Placebo cannabis

Outcomes

Primary Outcome Measures

Descriptor Differential Scale (DDS)

Secondary Outcome Measures

Changes in the use of opioid and non-opioid analgesics
Changes in measures of everyday functioning and subject-perceived quality of life
Adverse effects
Adverse cognitive effects as assessed by neuropsychological testing.

Full Information

First Posted
November 17, 2005
Last Updated
February 20, 2008
Sponsor
Center for Medicinal Cannabis Research
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1. Study Identification

Unique Protocol Identification Number
NCT00255580
Brief Title
Medicinal Cannabis for Painful HIV Neuropathy
Official Title
Placebo-Controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Center for Medicinal Cannabis Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
neuropathy, cannabis, marijuana, HIV, DSPN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Active cannabis (1-8% THC by weight)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo cannabis
Intervention Type
Drug
Intervention Name(s)
Smoked cannabis
Primary Outcome Measure Information:
Title
Descriptor Differential Scale (DDS)
Time Frame
Baseline, Post-treatment
Secondary Outcome Measure Information:
Title
Changes in the use of opioid and non-opioid analgesics
Time Frame
Post-Treatment
Title
Changes in measures of everyday functioning and subject-perceived quality of life
Time Frame
Baseline, Post-Treatment
Title
Adverse effects
Time Frame
Post-Treatment
Title
Adverse cognitive effects as assessed by neuropsychological testing.
Time Frame
Baseline, Post-Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Ellis, M.D., Ph.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego, Hillcrest Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cmcr.ucsd.edu
Description
Center for Medicinal Cannabis Research
URL
http://hnrc.ucsd.edu
Description
HIV Neurobehavioral Research Center

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Medicinal Cannabis for Painful HIV Neuropathy

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