Medicinal Cannabis for Painful HIV Neuropathy

Sponsor

Center for Medicinal Cannabis Research (Other)

Overall Status

Completed

CT.gov ID

NCT00255580

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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).

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.

Study Design

Study Type:

Interventional

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 :

Sep 1, 2001

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Nov 1, 2006

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Active cannabis (1-8% THC by weight)

Drug: Smoked cannabis

Placebo Comparator: 2

Placebo cannabis

Drug: Smoked cannabis

Outcome Measures

Primary Outcome Measures

Descriptor Differential Scale (DDS) [Baseline, Post-treatment]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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