Study # 423

What is the purpose of the research study?
To learn what happens to people when they use Sativex^®, an experimental drug that is made from the marijuana plant and is being considered as a treatment for pain.

Who can participate in the study?
This study is accepting men and women who:

• Are 18 to 45 years of age
• Use marijuana occasionally
• Are in generally good health

Healthy volunteers who do not use marijuana are also needed for this study; they will not be exposed to drugs of any kind.

What will participants be asked to do?
This study consists of 6 visits for both marijuana users and healthy volunteers. The first visit is a training session and lasts about 5 hours. The next 5 visits last about 12 hours each.

During these visits, participants who use marijuana will:

• Receive pills containing THC (the active ingredient in marijuana) or placebo (a pill with no drug)
• Receive Sativex^® or placebo sprayed into the mouth
• Have checks of heart rate, blood pressure, and breathing
• Provide urine, blood and oral fluid samples
• Complete questionnaires
• Take tests of thinking, attention, learning, and memory
• Participate in an MRI brain scan

Healthy volunteers will:

• Complete questionnaires
• Take tests of thinking, attention, learning, and memory
• Participate in an MRI brain scan

Where is the study taking place?
The NIDA Intramural Research Program is located on the Johns Hopkins Bayview campus in East Baltimore.

How much does it cost?
There is no cost for participation.

Will I receive payment of some kind?
All study participants will be compensated for their time and travel.

How can I find out if I’m eligible to participate?
Call 1-800-535-8254 for a confidential screening.