NCT00241579

Brief Summary

The purpose of this study is to determine whether or not inhaled marijuana displays any pain-relieving properties on experimentally-induced pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1 pain

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_1 pain

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

February 1, 2002

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2005

Completed
Last Updated

June 23, 2006

Status Verified

June 1, 2006

First QC Date

October 17, 2005

Last Update Submit

June 21, 2006

Conditions

PainHyperalgesia

Keywords

PainCannabisAnalgesic

Outcome Measures

Primary Outcomes (3)

  • Score on a Visual Analog Scale (VAS) of pain severity

  • McGill Pain Questionnaire (MPQ) Short Form

  • Neurosensory testing of: 1) warm and cold sensation, 2) warm and cold pain, 3) touch, and 4) mechanical pain. Testing administered using a Thermal Sensory Analyzer, von Frey hair filaments, and a pinch algometer, respectively.

Secondary Outcomes (2)

  • Trail Making Test (TMT) as a measure of psychomotor speed.

  • Paced Auditory Serial Attention Test (PASAT) as a measure of speed of information processing.

Interventions

Smoked CannabisDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-90
  • Male or Female
  • Subject smoked cannabis within the last six months

You may not qualify if:

  • Active opportunistic infections or opportunistic malignancies requiring acute treatment
  • Active substance abuse (alcohol or injection drug)
  • Pulmonary complications (e.g., tuberculosis, asthma)
  • Current use of cannabis (e.g., within 30 days of randomization)
  • Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test before any cannabis or placebo consumption condition
  • Personal or familial history of psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego Medical Center

San Diego, California, 92093, United States

Location

Related Links

MeSH Terms

Conditions

PainHyperalgesiaMarijuana Abuse

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersSensation DisordersNervous System DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Mark Wallace, M.D.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 17, 2005

First Posted

October 19, 2005

Study Start

February 1, 2002

Study Completion

January 1, 2004

Last Updated

June 23, 2006

Record last verified: 2006-06

Locations

US(1)