Medicinal Cannabis for Painful HIV Neuropathy

This study has been completed.
Sponsor:
Information provided by:
Center for Medicinal Cannabis Research
ClinicalTrials.gov Identifier:
NCT00255580
First received: November 17, 2005
Last updated: February 20, 2008
Last verified: February 2008

November 17, 2005
February 20, 2008
September 2001
November 2006   (final data collection date for primary outcome measure)
Descriptor Differential Scale (DDS) [ Time Frame: Baseline, Post-treatment ] [ Designated as safety issue: No ]
- Changes in pain magnitude as assessed by the Descriptor Differential Scale (DDS).
Complete list of historical versions of study NCT00255580 on ClinicalTrials.gov Archive Site
  • 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 ]
  • - Changes in the use of opioid and non-opioid analgesics.
  • - Changes in measures of everyday functioning and subject-perceived quality of life as assessed by the McGill Pain Questionnaire, the Neuropathic Pain Scale, the Sickness Impact Profile, and the Beck Depression Inventory.
  • - Adverse subjective effects as measured by the UKU Side Effect Rating Scale, the Brief Symptom Inventory (BSI), the Profile of Mood States (POMS), and the Highness/Sedation Scale.
  • - Adverse cognitive effects as assessed by neuropsychological testing.
Not Provided
Not Provided
 
Medicinal Cannabis for Painful HIV Neuropathy
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).

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neuropathic Pain
Drug: Smoked cannabis
  • Experimental: 1
    Active cannabis (1-8% THC by weight)
    Intervention: Drug: Smoked cannabis
  • Placebo Comparator: 2
    Placebo cannabis
    Intervention: Drug: Smoked cannabis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00255580
C00-SD-104
Yes
Ronald J. Ellis, M.D., Ph.D., University of California, San Diego
Center for Medicinal Cannabis Research
Not Provided
Principal Investigator: Ronald Ellis, M.D., Ph.D. University of California, San Diego
Center for Medicinal Cannabis Research
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP