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THC vs Smoked Marijuana in HIV/AIDS
NCT00079560Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2001
- Primary completion
- Aug 2004
- Countries
- 1
- Sponsor
- National Institute on Drug Abuse
- Modality
- Small Molecules
- Drugs
- dronabinolcannabis
- Conditions
- HIV-associated wasting syndrome (HIVAW)
01
Overview
Phase 2, randomised, double-blind trial in HIV-associated wasting syndrome (HIVAW) comparing Smoked Marijuana with Dronabinol (2 arms). Primary endpoint: Daily Caloric Intake. Started Dec 2001; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Smoked Marijuana
Smoked marijuana at 3 different doses
Dronabinol
Oral dronabinol at 3 different doses
03
Who it enrols
HIV infected individuals who currently smoke marijuana and are taking HIV medications. Excludes naive marijuana smokers and those with a history of respiratory/pulmonary disease.
04
Endpoints
Primary
Daily Caloric Intake
Secondary
Food Intake
Body Composition
Mood
Physical Symptoms
Psychomotor Task Performance
Sleep
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