NCT00046722

Brief Summary

To evaluate whether smoked marijuana reduces pain in people with HIV-related peripheral neuropathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2003

Typical duration 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

First Submitted

Initial submission to the registry

October 1, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2002

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

June 14, 2007

Status Verified

June 1, 2007

First QC Date

October 1, 2002

Last Update Submit

June 12, 2007

Conditions

Peripheral Nervous System DiseasesHIV Infections

Keywords

treatment experiencedcomplementary therapiesNeuropathyPeripheral NeuropathyHIV-Related Peripheral NeuropathyHIV

Outcome Measures

Primary Outcomes (1)

  • Change in level of HIV-related neuropathic pain as recorded on a 100mm Visual Analog Scale.

Secondary Outcomes (1)

  • Change in level of experimentally-induced pain.

Interventions

Smoked MarijuanaDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive.
  • Be 18 years or older.
  • Diagnosis of HIV-related painful neuropathy.
  • Stable antiretroviral therapy or no antiretroviral therapy for at least 8 weeks.
  • Prior use of marijuana, at least 6 occasions in their lifetime prior to enrollment.

You may not qualify if:

  • Current use of smoked tobacco products.
  • Current methadone treatment.
  • Use of smoked marijuana within 30 days of enrollment.
  • Diagnosis of diabetes mellitus.
  • Currently receiving treatment with corticosteroids.
  • Use of INH, dapsone or metronidazole within 8 weeks prior to enrollment.
  • Severe heart disease, uncontrolled high blood pressure or lung disease.
  • Women who are pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco Community Consortium

San Francisco, California, 94110, United States

Location

Related Publications (1)

  • Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.

    PMID: 17296917RESULT

Related Links

MeSH Terms

Conditions

Peripheral Nervous System DiseasesHIV Infections

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Donald I Abrams, M.D.

    UCSF Community Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2002

First Posted

October 3, 2002

Study Start

January 1, 2003

Study Completion

April 1, 2005

Last Updated

June 14, 2007

Record last verified: 2007-06

Locations

US(1)