NCT00079560

Brief Summary

Smoked marijuana (MJ) and dronabinol (also known as THC or by the trade name Marinol) are used to increase appetite, food intake, and weight in patients with HIV who experience unintended weight loss. This study will compare the effects of MJ and Marinol use in marijuana smokers who are HIV infected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Timeline
Completed

Started Dec 2001

Typical duration for phase_1 hiv-infections

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

December 1, 2001

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

January 11, 2017

Status Verified

October 1, 2008

Enrollment Period

2.7 years

First QC Date

March 9, 2004

Last Update Submit

January 10, 2017

Conditions

HIV Infections

Keywords

HIVMarijuanaMarinolOral THCAppetiteComplementary Therapies

Outcome Measures

Primary Outcomes (1)

  • daily caloric intake

    daily measure of colories

Interventions

dronabinolDRUG

dronabinol to prevent development of marijuana withdrawal

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV infected
  • Smoke marijuana
  • Taking HIV medications

You may not qualify if:

  • Naive marijuana smokers
  • People with history of respiratory/pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

HIV InfectionsMarijuana Abuse

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Margaret Haney, PhD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH
Expanded Access
Yes

Study Record Dates

First Submitted

March 9, 2004

First Posted

March 10, 2004

Study Start

December 1, 2001

Primary Completion

August 1, 2004

Study Completion

August 1, 2005

Last Updated

January 11, 2017

Record last verified: 2008-10

Locations

US(1)