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!
- Alcohol Treatment Studies
- Cocaine Treatment Studies
- Opioid Treatment Studies
- Imaging Studies (involving various substances)
- Observational Studies
- Collaborative Care PACE/PACENET Studies
Imaging Studies (involving various substances)
Pilot Study of a Multi-System Analysis of Opioid Receptor Binding
Substance of use: Opioids + healthy adults who are not using drugs
Age: 18-50
Study Description: In all three groups, we will use [11C]carfentanil whole-body PET imaging to examine the central nervous system (CNS) and broader systemic opioid binding in an initial scan session. In the two groups not receiving MAT for OUD, we will also examine the effects on [11C]carfentanil binding potential of the blockade of opioid binding by the non-selective opioid antagonist naloxone administered parenterally in a second scan session. This project will inform clinically relevant questions related to OUD and chronic pain.
Duration of Involvement: 6-8 weeks
Involvement: 4-5 visits total
- Screening/intake session (~2.5-3 hours)
- Baseline visit (~2.5-3 hours)
- Brain MRI scan (~1 hour)
- 1 or 2 PET scan visits (~3 hours)
Compensation Provided? Yes
Study Contact Number: (215) 746-1907
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
Opioid-induced brain damage in chronic pain patients and in patients with opioid use disorder (OUD).
Substance of Use: Opioids
Study Description: Both pre-clinical research (animal models) and recent clinical observations suggest that exposure to highly potent opioid agonists, especially fentanyl, may impact the brain’s memory circuitry and other neurocognitive functions. A subgroup of individuals with fentanyl-overdose have shown a profound amnestic syndrome that may reflect specific damage to the hippocampus, above and beyond the less specific effects of reduced oxygen to the brain during overdose. Thus, the overall hypothesis of this study is that patients with chronic pain or opioid use disorder (OUD) who have been on long-term, high-dose opioids (especially if they have had an overdose) may evidence hippocampal injury (loss of volume) and associated neurocognitive dysfunction. This hypothesis will be tested using a combination of MRI imaging and neuropsychological testing, involving a single MRI session, and a computerized task session. This NIH/NIDA-supported study is conducted by Dr. Andrew Kofke (Anesthesiology) and Dr. Paul Regier (Psychiatry, Center for Study on Addictions).
Age: 18-50
Populations: Medically-eligible males and females (non-pregnant) with chronic use of opioid agonists, either for pain or in Opioid Use Disorder (OUD), who are able to undergo an MRI and a single computerized task session.
Duration: MRI and computerized tasks can usually be completed on the same day.
Compensation: $200 for completion of the MRI, computerized tasks, and questionnaires.
Study Contact Numbers: 215-746-2767 or 215-746-7712
Opioid & Brain Study
Substance of Use: Opioids
Age: 18-60
Study description: Recovery from opioid use disorder is influenced by biological, psychological and social factors. This study aims to combine behavioral, clinical and MRI data to predict treatment outcomes for patients undergoing medication-assisted treatment for opioid use disorder. There is a screening visit that includes a urine drug test, physical exam, questionnaires, and interviews. Eligible participants will undergo an MRI followed monthly in-person visits, as well as optional weekly phone surveys and short daily text surveys. This is not a treatment study. MRI uses magnetic fields to take pictures of the brain. MRI does not use X-rays and is non-invasive.
Involvement:
- Consent and Screening Session (≈4 hours)
- Baseline visit & MRI scan (≈1 hour for MRI scan, ≈3 hours for surveys)
- Six monthly follow-up visits (≈1 hour each)
- Recommended weekly phone surveys (≈30 min each)
- Recommended daily text surveys (≈2 min each)
Duration of Involvement: ≈25 weeks
Compensation Provided? Yes
Study Contact: 215-746-7723
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
A Randomized, Double-blind Placebo-Controlled Study of Ibudilast for Treating Alcohol Use Disorder
Substance of Use: Alcohol
Age: 18-70
Study description: The goal of this study is to evaluate the safety and effectiveness of the drug Ibudilast compared to placebo (an inactive pill) in reducing the number of drinking days and the amount of alcohol consumed by people who want to stop or reduce their drinking. Use of this drug in the treatment of alcohol use disorder is experimental. Ibudilast is not approved by the Food and Drug Administration (FDA) clinical use in the United States. However, it has been used clinically for 20 years in Asia to treat bronchial asthma and, more recently, for post-stroke dizziness and eye allergies and has been shown to be safe and well tolerated. Recent clinical studies have provided support for the utility of Ibudilast in treating Alcohol Use Disorder.
Duration of Involvement: 12 weeks (6 weeks treatment + 1 month follow up visit)
Involvement: 7 or more visits to the University of Pennsylvania
- Visit 0: Consent + Screening Session (3 hours)
- Visit 1, Day 0: Baseline Assessments, randomization (1.5 hours)
- Visit 2, Week 1: 1st Bi-weekly visit - assessments, counseling (45 mins)
- Visit 3, Week 3: 2nd Bi-weekly visit - assessments, counseling (45 mins)
- Visit 4, Week 5: 3rd Bi-weekly - assessments, counseling (45 mins)
- Visit 5, Week 6: End-point visit - assessments, end of treatment (1 hour)
- Visit 6, 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 medication-assisted opioid treatment (MAT).
Substance of Use: Cocaine and Opioids
Age: 18-65 years old
Study Description: Pre-clinical data indicate that agents reducing overall activity at the brain’s dopamine D3 receptors may be helpful in blunting cue-triggered drug motivation (“craving”) states. Cariprazine, an atypical anti-psychotic already FDA-approved for thought and mood dysfunctions, has actions at D3 receptors, reduced cocaine-seeking in animals, and also (in pilot work) reduced the brain response to cocaine cues in reward/motivational circuits. This is a phase IIa, randomized, placebo-controlled pilot study designed to test whether low-dose cariprazine (1.5mg/d) can reduce cocaine use, and thus improve regular taking of MAT, in medically-stable OUD patients with co-occurring Cocaine-use Disorder who have already been taking prescribed buprenorphine-naloxone or methadone at a stable dose for at least one week. This NIH/NIDA-supported study is conducted by Drs. Kyle Kampman and Dr. Anna Rose Childress.
- Screening (approx. 1-2 weeks)
- Baseline (1-2 visits; includes baseline assessments, behavioral tasks/fNIRS session, and randomization)
- Outpatient treatment (8 wks; 2 visits/wk, includes daily cariprazine (or placebo), daily buprenorphine-naloxone or methadone (at the participants’ usual community treatment site), and brain imaging (fNIRS/fMRI), behavioral tasks after 10-17 days on cariprazine.
- Follow-up: A follow-up visit to assess medical and psychological status will occur approximately 1 week after the last dose of study medication.
Compensation: $25-$100 per visit, depending on the study activity
Study Contact Numbers: 215-746-2767 or 215-746-7712
Opioid Treatment Studies
ED-initiated Buprenorphine at Penn Presbyterian Medical Center
Substance of Use: Opioids
Study Description: Emergency physicians at Penn Presbyterian ED are leading a NIDA funded national study, ED-INNOVATION, to address the optimal formulation of buprenorphine for initiation of medication for opioid use disorder (MOUD). CAM2038 is a slow-release injection of buprenorphine that lasts for 7 days. The clinical outcomes at 7 days with CAM2038 will be compared to those with the conventional shorter-acting formulation of buprenorphine-naloxone (sublingual film). The study hypothesis is that the long-acting formulation may be a better ‘bridge’ to ongoing buprenorphine maintenance. The study team is led by Dr. Jeanmarie Perrone and includes colleagues Dr. David Jang, Dr. Anish Agarwal, Dr. Zachary Meisel and Dr. Sean Foster.
RIDE+
Substance of Use: Opioids with co-occuring diagnosis of HIV
Study Description: This CDC-funded research study will help us see whether providing medical services in a mobile unit will help persons who inject drugs (PWID) start and stay on anti-HIV medicines and medicines for opioid use disorder better. All participants will be assigned to one of two groups by random chance (the equivalent of throwing dice). The difference between the groups is that the first group will receive health care services delivered on a mobile unit. These services include medication for opioid use disorder, HIV testing, HIV treatment for people living with HIV and not in care, pre-exposure prophylaxis (PrEP) for people who do not have HIV, and STI testing and treatment. The second group will have their initial Screening and Enrollment Visits in the mobile unit, but all other visits will occur in regular clinics in the area. Participants in both groups will be assigned a peer navigator for 26 weeks who will assist participants in accessing and remaining in medical care. All participants will come in for study assessments at approximately six and 12 months after starting the study and will be in the study for about a year total. The study is led by Dr. Dave Metzger and Dr. Cecile Denis.
Sign up online here!
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:
- Screening (approx. 1-2 weeks)
- Baseline (1-2 visits; includes baseline assessments, behavioral tasks/fNIRS session, and randomization)
- 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.
- 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
Observational Studies
Acute effects of ketone supplementation on subjective and objective responses to alcohol in healthy volunteers
Substance of Use: Alcohol
Age: 21-50
Study description: The goal of this study is to examine the influence of nutritional ketone supplement (Kenetik: Ketone Concentrate, VitaNav Inc.) on immediate subjective and objective effects of alcohol. We will provide a single dose of ketone supplement beverage or an inactive placebo beverage on two separate study visits. A dose of alcohol calculated to elevate breath alcohol concentration to approximately 0.05% will be administered and followed by assessment for blood and breath alcohol levels and questionnaire responses. This is not a study to help you quit or reduce your drinking.
Duration of Involvement: up to 1 month
Involvement: 3 or more visits to the University of Pennsylvania
- Consent + Screening Session (2 hours)
- Study visit #1 (5.5 hours)
- Study visit #2 (5.5 hours)
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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