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 (4-5 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!

Effects of a ketone ester on brain function and alcohol consumption in alcohol use disorder: 7T Scan (Sub-study)

Substance of Use: Alcohol
Age: 21-65
Study description: This is not a study to help you quit or reduce your drinking. The purpose of this research is to study how brain energy levels and brain function may differ with people who drink alcohol on a regular weekly basis. We will measure levels of Nicotinamide adenine dinucleotide (NAD) in brain cells, which a coenzyme that is important for energy metabolism. 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. This study is open to frequent alcohol users and non-alcohol users. 

Duration of Involvement: Up to 8 weeks
Involvement: 3 sessions at the University of Pennsylvania

  • Consent + Screening Session (4-5 hours)
  • 7-Tesla MRI scan session (2 hours)
  • 3-Tesla MRI scan session (2 hours)

Compensation Provided? Yes
Study Contact Number: (215) 746-1987

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


Testing the Reward-Drinker Hypothesis of Naltrexone Using an Extended-Release Formulation

Substance of Use: Alcohol
Age: 18-65
Study description: This study is testing the efficacy of extended-release naltrexone injection vs. placebo in helping to reduce heavy drinking with people who are primarily reward drinkers. Participants must desire to reduce or stop drinking to participate. This is a double-blind, placebo-controlled clinical trial with a treatment phase that lasts 8 weeks. During the 8-week study medication period, you will be asked to come to the CSA every other week. You will also complete daily interactive voice response (IVR) system assessments via your telephone. This will take less than 5 minutes/day.
Duration of Involvement: 12 weeks
Involvement: 6 or more visits to the University of Pennsylvania

  • Start: Consent + Screening Session (3 hours)
  • Week 0: Baseline Assessments, randomization + 1st injection (1.5 hours)
  • Week 2: 1st Bi-weekly visit - assessments, counseling (45 mins)
  • Week 4: 2nd Bi-weekly visit - assessments, counseling + 2nd injection (45 mins)
  • Week 6: 3rd Bi-weekly - assessments, counseling (45 mins)
  • Week 8: End-point visit - assessments, end of treatment (1 hour)
  • Week 12: Follow-up - assessments, debrief (1 hour)

Compensation Provided? Yes
Study Contact Number: (215) 746-1987

Cocaine Treatment Studies


A  Phase 2a  randomized, single-blind, placebo-controlled pilot study to evaluate the impact of cariprazine (1.5mg) on cocaine use in OUD-CocUD patients on buprenorphine-naloxone. 

Substance of Use: Cocaine and Opioids
Age: 18-65 years old
Study Description: This is a phase IIa, randomized, placebo-controlled pilot study designed to examine whether low-dose cariprazine (1.5mg/d) impacts cocaine use in medically-stable OUD patients with co-occurring CocUD who have already been taking BUP-NX at a stable dose for at least one week (up to 24mg buprenorphine/6mg naloxone daily).  To be eligible for this relapse-prevention study, patients will have a cocaine-negative urine at the time of study enrollment.  
Duration: The study has 4 distinct phases:

  1. Screening (approx. 1-2 weeks)
  2. Baseline (1-2 visits; includes baseline assessments, behavioral tasks/fNIRS session,  and randomization)
  3. Outpatient treatment (8 wks; 2 visits/wk, includes daily cariprazine (or placebo), daily BUP-NX (at the participants’ usual community treatment site), and imaging (fMRI and fNIRS)/behavioral tasks at steady-state.
  4. Follow-up: A follow-up visit to assess medical and psychological status will occur approximately 1 week after the last dose of study medication.

Study Contact Numbers: 215-746-2767 or 215-746-7712

Opioid Treatment Studies


A  Phase 2a  randomized, single-blind, placebo-controlled pilot study to evaluate the impact of cariprazine (1.5mg) on cocaine use in OUD-CocUD patients on buprenorphine-naloxone. 

Substance of Use: Opioids and Cocaine
Age: 18-65 years old
Study Description: This is a phase IIa, randomized, placebo-controlled pilot study designed to examine whether low-dose cariprazine (1.5mg/d) impacts cocaine use in medically-stable OUD patients with co-occurring CocUD who have already been taking BUP-NX at a stable dose for at least one week (up to 24mg buprenorphine/6mg naloxone daily).  To be eligible for this relapse-prevention study, patients will have a cocaine-negative urine at the time of study enrollment.  
Duration: The study has 4 distinct phases:

  1. Screening (approx. 1-2 weeks)
  2. Baseline (1-2 visits; includes baseline assessments, behavioral tasks/fNIRS session,  and randomization)
  3. Outpatient treatment (8 wks; 2 visits/wk, includes daily cariprazine (or placebo), daily BUP-NX (at the participants’ usual community treatment site), and imaging (fMRI and fNIRS)/behavioral tasks at steady-state.
  4. Follow-up: A follow-up visit to assess medical and psychological status will occur approximately 1 week after the last dose of study medication.

Study Contact Numbers: 215-746-2767 or 215-746-7712

Combining Pregabalin (LYRICA®) with Lofexidine (LUCEMYRATM): Can it Increase the Success of Transition to Naltrexone?

Substance of Use: Opioids
Age: 18+ years old
Study Description: This study is a phase II, two-part randomized, double-blind placebo-controlled, study to assess the effectiveness of PGB combined with LFX to reduce opioid withdrawal- related subjective effects, and to examine whether a PGB/LFX combination can increase the proportion of opioid use disordered (OUD) subjects who transition to antagonist treatment (XR-NTX).

The study will use three sites, each with inpatient units that provide beds and care from nurses that will be trained in study procedures and dosing requirements.  Each site will recruit 30 randomized subjects, for a total sample size of 90, using DSM-5 to establish an OUD diagnosis with physiologic features. 
Duration: The study has 4 distinct phases; otal days in study is 15 days plus or minus the time taken to complete the initial outpatient screening assessments. Randomization will occur before inpatient admission.

  1. Outpatient Screening
  2. Inpatient medication induction plus other assessments on Days 1-7
  3. Inpatient XR-NTX administration on Day 8 or 9
  4. Outpatient Follow-Up (5 days)

Study Contact Number: 215-746-0467

Nicotine Research Studies


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!

Collaborative Care PACE/PACENET Studies


SUSTAIN (SUpporting Seniors receiving Treatment And INtervention)

Age: 65+ years old
Study Description: 100% telephone based Clinical Program with a waiver of consent for retrospective chart review. Collaborative care visit summary reports are faxed to the prescribing physician. Initial Baseline completed with psych tech. Patient-preference follow-up services are offered to eligible subjects with recommendations made based on symptomatology. Depression/ Anxiety/ Medication monitoring for 12 weeks with psych technician. Care Management services with Behavioral Health Providers for 26 weeks.
Study Contact Number: 215-746-7721

CREST (Caregiver Resources, Education, & SupporT)  

Age: 65+ years old
Study Description: PACE/ PACENET enrollee’s caregiver is considered research subject. 100% telephone-based support program, aimed at providing CG’s with assistance connecting to resources, dementia related education, and problem solving. Caregiver Baseline completed with psych tech. Follow-up Service offered:

  • Care Management and “Telehealth Education Program for Caregivers of Older Adults with Dementia” provided by Behavioral Health Providers for up to 26 weeks. 

A one time 6 Month Research call with psych technician concludes participation.
​​​​​​​Study Contact Number: 215-746-7721


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