Department of Psychiatry

Penn Behavioral Health

Current Addiction Treatment Research Studies

If you would like to discuss eligibility in one of our clinical trials, please call the specific number listed with the study.

If you have questions about more than one study, please call 215-746-0222.

Clinical Trials

The Addiction Treatment and Medication Development Division is conducting a number of clinical trials that are on-going or soon to begin.

 

Alcohol Treatment Studies


A Randomized, Double-blind Placebo-Controlled Pharmacogenetic Study of Topiramate in European-American Heavy Drinkers (Top G)

Substance of Use: Alcohol
Age: 18-70 years old
Study Involves: In-clinic visits at the Treatment Research Center once a week for the first 6 weeks, and then every other week for the last 7 weeks. Each of the two initial visits last for about 2 hours, with subsequent appointments generally lasting about 1/2 hour.  At these visits, a research nurse will meet with you to review how you are doing with the study medication. She will also provide you with brief counseling.  You will also be asked to spend about 5 minutes per day completing a computerized phone interview.  During the course of the study, you will be given either the active medication (topiramate) or an inactive placebo to take on a daily basis. Whether you receive topiramate or placebo will be a random decision, like the flip of a coin.  You have a 1 in 2 chance of being assigned to either group.  This study also has a follow-up phase.  You will be asked to return for two follow-up appointments 3 and 6 months after you finish the course of study medication.  These visits will involve blood work, questionnaires, and an interview.  
Duration:13 weeks and two follow-up appointments 3 and 6 months after you finish the course of study medication
Study Contact Number: 215-746-1987 

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder (OND)

Substance of Use: Alcohol
Age: 18-65 years old
Study Involves: Study treatment period will last 16 weeks – brief counseling included. There will also be a screening visit including bloodwork, urine drug test, ECG, physical exam and questionnaires. During the course of the study, you will be given either the active medication (ondansetron) or an inactive placebo to take on a daily basis. Whether you receive ondansetron or placebo will be a random decision, like the flip of a coin.  You have a 1 in 2 chance of being assigned to either group.  This study also has a follow-up phase at 20 weeks.  
Duration: 16 weeks plus one  follow-up appointment at 20 weeks after you finish the course of study medication.
Study Contact Number: 215-746-1987

 

Cocaine Treatment Studies


Testing Cariprazine, A partial Agonist at Dopamine D3 Receptors, in Cocaine Use Disorders

Substance of Use: Cocaine
Age: Adult males and females
Study description: The brain’s dopamine D3 receptors are located in motivational circuits that may be very important in addiction relapse, including cue-triggered drug motivation (drug desire, or “craving”) and relapse. Cariprazine is a medication that is known to act on D3 receptors, so two cariprazine studies are testing whether cariprazine can reduce cue-triggered brain activation in patients with cocaine use disorder, and whether the medication (as compared to inactive placebo) may also reduce outpatient cocaine use.

Cariprazine is known to be safe for humans and is already FDA-approved for management of mood problems; the two studies at Penn are the first tests of cariprazine in substance use disorders. Both studies feature a screening period, a two-week inpatient phase (prior to brain imaging), and an eight-week outpatient treatment phase. Compensation for research participation is provided for study eligibility screening, for imaging, for travel to outpatient appointments, and for completion of study measures. The two cariprazine studies differ in the medication dose that is tested, as it is not yet known which dose level of cariprazine may be more effective for substance use disorders.

Cariprazine_1500 will test 1.5 mg of medication vs. placebo. This study is supported by an NIH Center for the Development of Novel Medications for Cocaine Dependence (NIH/NIDA U54_DA039002; Center Director, Kyle Kampman, M.D., Imaging Project Principal Investigator, Anna Rose Childress, Ph.D.).

Cariprazine_3000 will test 3.0 mg of medication vs. placebo. This study is supported by an individual NIH grant, Targeting dopamine D3 receptors in cocaine addiction (NIH/NIDA R01DA039215, Principal Investigator, Anna Rose Childress, Ph.D.)

Duration: 10 weeks
Study Contact Number: 215-746-3708

A Phase II, Double-blind, Placebo-Controlled, Trial of NS2359 for the Treatment of Cocaine Dependence (DANA) 

Substance of Use: Cocaine
Age: 18-70 years old
Study involves: Three visits weekly for the purposes of medical management (MM), cognitive behavioral therapy (CBT), to complete questionnaires and assess drug compliance
Duration: 9 weeks plus follow-up visit
Study Contact Number: 215-746-3708

Brain mechanisms of relapse and recovery in males with cocaine use disorder: a BOLD fMRI study (OPS)

Substance of Use: Cocaine
Age: 18-60 years old
Study involves: An imaging study that requires an inpatient stay of 7-10 days, and an outpatient treatment period of 8 weeks with drug counseling. The purpose is to understand if brain responses to drug cues predict drug use.
Duration: 10 weeks
Study Contact Number: 215-746-1829

Evaluation of D3 Receptor Occupancy Using [18F] Fluortriopride ([18F]FTP) PET/CT (D3PET)

Substance of Use: Cocaine
Age: 18-60 years old
Study involves: An imaging study that requires an inpatient stay of 7-10 days, and an optional outpatient treatment period of 3 weeks with drug counseling. The purpose is to understand the role of receptors involved with cocaine.
Duration: 1 to 4 weeks
Study Contact Number: 215-746-1829

 

Opioid Treatment Studies


None currently. Please check again at a later date.

 

Nicotine Treatment Studies


Placebo-controlled trial of bupropion for smoking cessation in pregnant women (BIBS)

Substance of Use: Nicotine
Age: 18 years or older (female)
Who can take part:  Pregnant women who smoke regularly, want to quit smoking, and in their second trimester (13-26 weeks) of pregnancy 
Study Involves: This is a research study testing whether a medication called bupropion can help pregnant women quit smoking. Bupropion is an antidepressant that is already used to help non-pregnant adults quit. Bupropion is also used to treat depression in pregnant women, but has not been formally tested to help pregnant women quit smoking. It is important for pregnant smokers to quit smoking because it reduces the risk of health problems for both them and their babies. There are: 6 in-person and 4 phone sessions, two blood samples, taking bupropion or placebo (a “sugar pill”) for 10 weeks, daily text messages that remind you to take study medication with helpful information about your child’s development, three follow up contacts, two of which will be done by telephone after your baby is born.
Duration: 10 weeks plus 3 follow up visits
Study Contact Number: 215-746-1954

 

Nicotine Research Studies


Influence of the Natural Hormonal Milieu on Perfusion fMRI Smoking Cue Responses (MCS)

Substance of Use: Nicotine 
Age: 18-45 years old  (female)
Study Involves: This is a 3 - 4 month study examining the influence of hormones on the brain and behavior. This is NOT a Quit Smoking study. Participants in the study will be women between the ages of 18-45 with a regular menstrual cycle who smoke cigarettes. Evidence from other studies suggests that the hormones that are released in a woman’s body over the course of the menstrual cycle have effects on the brain, which may influence how they feel and behave. The study will involve 3 MRI Test Days over 3 menstrual cycles. MRI tasks will include exposure to smoking cues and actual smoking. Neurobehavioral tasks will also be administered on Test Days. Hormone levels will be monitored. Through the use of a computer or smart phone participants will keep a daily account of smoking behavior and other behaviors, such as alcohol and substance use, libido, and food consumption over the course of their participation. They will also monitor when they ovulate from home. The findings of these brain scans will help scientists understand the influence of hormones on the brain and behavior. Women who smoke cigarettes, who are not interested in quitting smoking or becoming pregnant during study participation, who have a regularly occurring menstrual cycle and who are not taking exogenous hormones (i.e., hormonal birth control) may be eligible to participate. Compensation is provided.
Duration: 3 to 4 months, 10 visits
Study Contact Number: 215-746-1896

Biobehavioral Effects of Tobacco Labeling and Packaging (GWL)

Substance of Use: Nicotine
Age: 18-55 years old 
Study Summary: This is a study of current smokers' brain responses to tobacco-related images. Eligible participants will be provided with cigarettes at no cost. The study includes five weekly visits and 2 functional Magnetic Resonance Imaging (MRI) scans of the brain. MRI uses magnetic fields to take pictures of the brain. MRI does not use X-rays and is non-invasive.
Duration: 5 weekly visits, and 2 monthly follow-up visits
Study Contact Number: 215-746-0150 or 215-756-0278


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