Treatment Trials and Imaging Studies

If you would like to discuss eligibility in one of our clinical trials, please call the specific number listed with the study or click on the link to sign up online.

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. You do not have to use substances or drink alcohol to be eligible for our studies!

Imaging Studies (involving various substances)


Evaluation of in vivo Neuroinflammation Using 18F-NOS Positron Emission Tomography (PET/CT) in HIV Positive and Negative Subjects with Opioid Use Disorder and Healthy Controls

Substance of Use: Opioids
Age: 18-60
Study description: The purpose of this research is to measure the extent of inflammation in the brain between different groups of participants using a radioactive drug called [18F]NOS that is injected into the body and used to create images. This study will see how the drug is taken up in the brain using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). This is not a treatment study.

[18F]NOS is an experimental radioactive imaging drug used in PET imaging to measure inflammation in various organs in the body, including the brain. We are interested in studying whether there are differences in brain inflammation between people that have a history of opioid drug use and those that do not and in people that are HIV positive or negative. You may have neither, one, or both of these conditions. [18F]NOS has not yet been approved by the Food and Drug Administration (FDA) for use except in a research study. The use of [18F]NOS in this study is allowed under an Investigational New Drug Application approved by the FDA.

We are also going to be studying how the information from the PET/CT scan compares to other markers of inflammation in the blood and we will also compare it to other psychological testing measures and information about use of opioids. We will do a brain scan to see if there is a difference between inflammation seen in the brain depending on which group you are in (HIV +/- and history of opioid use or none).

Duration of Involvement: 6 weeks
Involvement: 4 sessions at the University of Pennsylvania + 1 phone-call:

  • Consent and Screening Session (~3 hours)
  • Baseline Session (~2 hours)
  • MRI scan (~1 hour for scan)
  • PET session (~3 hours, 1 hour for scan + 2 hours for assessments)
  • Follow-up phone call

Compensation Provided? Yes
Study Contact Number: (215) 746-1987
Sign up Online here!

The influence of Nicotinic Hepatic Metabolismon Neuroreceptor Substrates of Nicotine Addiction

Substance of Use: Nicotine
Age: 18-65
Study description: The purpose of this study is to image the effects of nicotine on brain receptors and whether 2-[18F]FA uptake changes after different amounts of time without smoking or with the injection of nicotine. The imaging procedure we are using is called Positron Emission Tomography (PET/CT). [18F]NOS has not yet been approved by the Food and Drug Administration (FDA) for use except in a research study. The use of [18F]NOS in this study is allowed under an Investigational New Drug Application approved by the FDA. Intravenous (liquid) nicotine is an experimental drug that is similar to the nicotine that is the primary active compound in cigarettes. In this study a small dose of liquid nicotine will be injected during the PET imaging procedure. This is not a quit-smoking study.

Duration of Involvement: 4 months
Involvement: 4 visits at the University of Pennsylvania, including 1 overnight stay + 2 follow-up phone calls:

  • Consent and Screening Session (~3 hours)
  • MRI scan (~1 hour for scan)
  • PET session #1 (~9 hours, 1.5 hours for scan + 7 hours for assessments and infusion)
  • PET session #2 includes an overnight stay the day before the scan (~9 hours, 1.5 hours for scan + 7 hours for assessments and infusion)
  • Follow-up phone call after each PET session

Compensation Provided? Yes
Study Contact Number: (215) 746-1987
Sign up Online here!

Measurement of Pulmonary Inflammation Using 18F-NOS Positron Emission Tomography (PET/CT) in E-cigarette Users

Substance of Use: Nicotine and/or Cannabis
Age: 18-45
Study description: The purpose of this research is to measure the extent of lung inflammation between different groups of participants using a radioactive tracer called [18F]NOS. A radioactive tracer is a type of imaging drug that is labeled with a radioactive tag and injected into the body. This study will see how the tracer is taken up in the lungs using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT).[18F]NOS is an experimental radioactive molecule used in PET imaging to measure inflammation in various organs in the body. This is not a quit-smoking study.

We are interested in studying whether there are differences in lung inflammation between e-cigarette users (vapers) of either nicotine or cannabis, cigarette smokers, dual users (uses e-cigs/vapes and smokes) and non-smokers. [18F]NOS has not yet been approved by the Food and Drug Administration (FDA) for use except in a research study. The use of [18F]NOS in this study is allowed under an Investigational New Drug Application approved by the FDA.

Duration of Involvement: 6 weeks
Involvement: 2 visits at the University of Pennsylvania + 1 follow-up phone call:

  • Consent and Screening Session (~4 hours)
  • PET session (~2 hours, 1 hour for scan + 1 hour for assessments)
  • Follow-up phone call after PET session

Compensation Provided? Yes
Study Contact Number: (215) 746-1987
Sign up Online here!

Effects of a nutritional ketone ester on brain function and alcohol consumption in alcohol use disorder

Substance of Use: Alcohol
Age: 21-65
Study description: The purpose of this research is to study how a nutritional ketone ester may effect brain function and alcohol consumption in regular alcohol users. The ketone ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, is a ketone monoester that has been studied in humans and is FDA approved as a nutritional supplement (FDA GRAS). The study will see how the brain responds, once after drinking the ketone ester and once after drinking a “placebo”, which will look and taste the same as the ketone ester drink. We will not tell you which drink is which. We will study the brain using MRI, which is a large magnet. We will test how your brain functions at rest and while viewing pictures of alcohol. We are also interested in if the ketone ester makes you want to drink alcohol more or less. This is not a study to help you quit or reduce your drinking.

Duration of Involvement: up to 8 weeks
Involvement: 4 sessions at the University of Pennsylvania

  • Consent + Screening Session (3-4 hours)
  • 1st in-person study visit that includes the drinking of the ketone ester, a brain MRI scan and alcohol drinking after the scan (~7-8 hours)
  • 2nd in-person visit that includes the drinking of a placebo, a brain MRI, and alcohol drinking after the scan (~7-8 hours)

Compensation Provided? Yes
Study Contact Number: (215) 746-1987
Sign up Online here!

Relationship between brain and heart glucose metabolism in Alcohol Use Disorder

Substance of Use: Alcohol
Age: 21-65
Study description: The goal of this study is to learn more about how a nutritional supplement “ketone ester” (deltaG®) influences brain and heart function and alcohol consumption in individuals with and without alcohol use disorder. We will study this using Fluorodeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scans after a single dose of ketone ester and at baseline (no drink). This is not a study to help you quit or reduce your drinking.

Duration of Involvement: up to 8 weeks
Involvement: 4 or more visits to the University of Pennsylvania

  • Consent + Screening Session (4-5 hours)
  • PET Scanner Visit #1 (3-4 hours)
  • PET Scanner Visit #2 (3-4 hours)
  • MRI Visit (1 hour)

Compensation Provided? Yes
Study Contact Number: (215) 746-1987
Sign up Online here!

Alcohol Treatment Studies


There are currently no ongoing alcohol treatment studies at our center. Please check again soon, as studies are updated on a periodic basis.

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


Remote Observed Dosing to Improve Suboxone Compliance in Clinical Practice (RODISC)

Substance of Use: Opioids
Age: 18-45 years old
Study Involves: This is a research study examining whether remote observed dosing (i.e., video recordings) helps to improve medication adherence. The RODS study offers a 12-week Suboxone treatment for opioid-dependent individuals. There is a baseline screening visit that includes bloodwork, a urine drug test, physical exam, and questionnaires. Participants will be randomly assigned to one of two groups: the remote observed dosing group or the attention control group. The remote observed dosing group will submit daily video recordings of taking their Suboxone dose. The attention control group will send a text message confirming that they took their daily Suboxone dose. Both groups receive 12-weeks of Suboxone as well as a study phone with a capped talk, text, and data plan. Participants will come in twice a week for study visits.
Duration: The entire study runs for 15 weeks.
Study Contact Number: 215-746-1990

 

Nicotine Research Studies


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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