Medicinal Cannabis for Painful HIV Neuropathy

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255580
• Other study ID #: C00-SD-104
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 17, 2005
• Last updated: February 20, 2008
• Start date: September 2001
• Est. completion date: November 2006

Study information

• Verified date: February 2008
• Source: Center for Medicinal Cannabis Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Smoked cannabis

Locations

Country	Name	City	State
United States	UC San Diego, Hillcrest Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Center for Medicinal Cannabis Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptor Differential Scale (DDS)		Baseline, Post-treatment	No
Secondary	Changes in the use of opioid and non-opioid analgesics		Post-Treatment	No
Secondary	Changes in measures of everyday functioning and subject-perceived quality of life		Baseline, Post-Treatment	No
Secondary	Adverse effects		Post-Treatment	Yes
Secondary	Adverse cognitive effects as assessed by neuropsychological testing.		Baseline, Post-Treatment	Yes

External Links

•   Center for Medicinal Cannabis Research
•   HIV Neurobehavioral Research Center