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 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


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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