Department of Psychiatry

Penn Behavioral Health

Addiction Treatment and Medication Development Division

Clinical Trials

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

If you are interested in getting more information about any of these studies, please call 215-243-9959.

For recent news at the CSA, please click on newsletter links below!



Alcohol Treatment Studies

Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of HORIZANT® (Gabapentin Enacarbil) Extended-Release Tablets for the Treatment of Alcohol Use Disorder (Horizant) 

Diagnosis: Alcohol Use Disorder
Age:  21 and up
Study Involves: Alternating phone and in-clinic visits for medical management (MM), laboratory tests, and physical exams, to assess drug compliance, to complete additional questionnaires, and to provide counseling (via “Take Control” videos) over 29 weeks. 
Duration: Up to 7 months including follow up
Study Status: Active – recruiting participants
Study Contact Number: 215-243-9959

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

Diagnosis: Alcohol Use Disorder
Age: 18-70
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 Status: Active – recruiting participant
Study Contact Number: 215-222-3200 x 193


Cocaine Treatment Studies

Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence: A Phase III, Randomized, Double-Blind Trial of Adderall-XR and Topiramate (TACT)

Diagnosis or Problem: Cocaine Dependence
Age: 18-60
Study involves: Three visits weekly that include medical management (MM) and a supportive behavioral treatment to enhance adherence to the study drug
Duration: 15 weeks plus follow up visit
Study Status: Active – recruiting participants
Study Contact Number: 215-243-9959

A Phase II Randomized, Double-blind, Placebo-Controlled,  Trial of Varenicline (Chantix™) for the Treatment of Cocaine Dependence (Chantix Cocaine 2)

Diagnosis or Problem: Cocaine Dependence
Age: 18-65
Study involves: Three visits weekly for the purposes of medical management (MM), cognitive behavioral therapy (CBT), to complete questionnaires and assess drug compliance
Duration: 12 weeks
Study Status: Active – recruiting participants
Study Contact Number: 215-243-9959


Opioid Treatment Studies

A Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of Naltrexone for use in Conjunction with Buprenorphine in Adults with Opioid Use Disorder Prior to First Dose of VIVITROL® (Alkermes)

Diagnosis or Problem: Opioid Use Disorder 
Age:  18-60 years of age
Study Involves: Up to 16 weeks, including Screening (up to 3 weeks), 1 week treatment period with active or placebo study drug, and 12 weeks for Follow-up including second and third VIVITROL® injections.
Duration: 16 weeks
Study Status: Active - recruiting participants 
Study Contact Number: 215-243-9959


Nicotine Treatment Studies

Phase 2, Multi-Center Trial of AZD8529 for Smoking Cessation in Female Smokers (AZD)

Diagnosis or Problem: Nicotine dependence 
Age: 18-75, this study is specifically for treatment seeking women
Study Involves: Up to 19 weeks, including screening (up to 2 weeks), maintenance/active study drug treatment (12 weeks), and follow-up (Week 17)
Duration: 19 weeks (including 2 week screening period)
Study Status: Active - recruiting participants 
Study Contact Number: 215-222-3200 x204

Baclofen effects on brain and behavior in cigarette smokers (BAC)

Diagnosis or Problem: Nicotine dependence 
Study Summary: The purpose of our research is to study a medication that may help you quit smoking. We also want to learn more about how this medication impacts your response to smoking cues, or reminders, in your environment that may cause you to crave cigarettes. In this study, the medication (baclofen) is being compared to a placebo, which is a pill that looks like the medication but has no active ingredients. If you qualify for the study, you have a 1 in 2 (50%) chance of receiving the medication; if you don’t receive the medication, you’ll receive the placebo. This study is double-blinded. That simply means that neither you, nor any member of the research team, will know whether you are receiving the medication or the placebo; this is an important way of studying the effectiveness of the medication without biasing our results in any way. Given that genetics play a large role in smoking behavior, we are also studying some genes that are involved in smoking.
Age: 18-60 years 
Study Involves: Baclofen or placebo (double-blind), 2 fMRI scans, plus weekly medication monitoring by our medical staff.
Duration: 8 weeks of treatment (including 2 fMRI scans) plus 1 week of follow-up
Study Status: Active - recruiting participants 
Study Contact Number: 215-222-3200 x188

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

Diagnosis or Problem: Nicotine Dependence
Who can take part:  Pregnant women who smoke regularly and are:

  • 18 years or older
  • Want to quit smoking
  • 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 Status: Active - recruiting participants 
Study Contact Number: 215-222-3200 ext 161

Use of SPECT to examine DAT binding and Trafficking in cigarette dependence (DDAT2)

Diagnosis or Problem: Nicotine dependence 
Study Summary: Studies demonstrate that genetics may play a role in smoking behavior. We will use a brain imaging technique called single photon emission computerized tomography (SPECT/CT) to help us learn more about how genetics can influence your motivation to smoke. SPECT/CT is a special camera that uses a radiotracer called DaTscan that provides information about your brain. If we can understand how genetics and smoking behavior interact, we may be able to develop personalized treatment options that can help individuals quit.
Age: 18-60, Males
Study Involves: Consent Visit, Screening Visit, 2 SPECT/CT scans, max of 2 Double-Booking sessions
Duration: Approximately 6 weeks (including 2 week screening period)
Study Status: Active - recruiting participants 
Study Contact Number: 215-222-3200 x188


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