NCT00255580

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

February 28, 2008

Status Verified

February 1, 2008

Enrollment Period

5.2 years

First QC Date

November 17, 2005

Last Update Submit

February 20, 2008

Conditions

Neuropathic Pain

Keywords

neuropathycannabismarijuanaHIVDSPN

Outcome Measures

Primary Outcomes (1)

  • Descriptor Differential Scale (DDS)

    Baseline, Post-treatment

Secondary Outcomes (4)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Active cannabis (1-8% THC by weight)

Drug: Smoked cannabis

2

PLACEBO COMPARATOR

Placebo cannabis

Drug: Smoked cannabis

Interventions

Smoked cannabisDRUG
12

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego, Hillcrest Medical Center

San Diego, California, 92103, United States

Location

Related Links

MeSH Terms

Conditions

NeuralgiaMarijuana Abuse

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Ronald Ellis, M.D., Ph.D.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2005

First Posted

November 21, 2005

Study Start

September 1, 2001

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

February 28, 2008

Record last verified: 2008-02

Locations

US(1)