NCT00046709

Brief Summary

To find out if it is safe and effective to use smoked marijuana in combination with opioids to treat cancer pain. The study will evaluate whether smoked marijuana, when used with opioids, will have an effect on pain relief, and to see if marijuana reduces the side effects of opioids, which include nausea and/or vomiting.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2002

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2002

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

October 10, 2013

Status Verified

October 1, 2013

First QC Date

October 1, 2002

Last Update Submit

October 9, 2013

Conditions

Neoplasms

Keywords

Cancer painAll types of cancer except lung cancer

Outcome Measures

Primary Outcomes (1)

  • Change in level of cancer pain as recorded on a 100mm Visual Analog Scale.

Secondary Outcomes (3)

  • Change in level of experimentally induced pain on a 100mm Visual Analog Scale.

  • Change in nausea and emesis in participants exhibiting these symptoms.

  • Change in disposition kinetics of opioid analgesics.

Interventions

Smoked MarijuanaDRUG

Eligibility Criteria

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

You may qualify if:

  • Have ongoing cancer pain
  • Be diagnosed with cancer and have at least a six month survival.
  • Be on a stable dose of opioid medication for at least 2 weeks before enrollment.
  • Have smoked marijuana on at least 6 occasions in their lifetime prior to enrollment.

You may not qualify if:

  • You must not:
  • Start chemotherapy, radiation or biphosphonates during the study, or have received any new intervention with any such agents within the past 4 weeks.
  • Currently be using smoked tobacco products.
  • Currently be in methadone treatment.
  • Have smoked marijuana within 30 days of enrollment.
  • Be diagnosed with diabetes mellitus.
  • Have severe heart disease, uncontrolled hypertension, or lung disease.
  • Currently be receiving treatment with corticosteroids.
  • Be pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsCancer Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Donald I Abrams, M.D.

    UCSF Community Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2002

First Posted

October 2, 2002

Study Start

September 1, 2002

Study Completion

October 1, 2004

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations

US(1)