Actively Recruiting
Targeting Immune Inflammation in Cocaine Use Disorder: A Human Laboratory Study With Pentoxifylline
Led by William Stoops · Updated on 2026-06-08
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
William Stoops
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of pentoxifylline treatment on cocaine use disorder in a human laboratory setting. This early phase 1 study is part of the Helping to End Addiction Long-term® (HEAL) Initiative, focusing on how pentoxifylline may influence the effects of cocaine in adults aged 18 to 55 years who use cocaine. The research aims to better understand potential treatments for cocaine use disorder while evaluating immune inflammation targeting strategies. Participants will be randomly assigned to one of three groups: a daily oral placebo group, or daily oral pentoxifylline at doses of 1200 mg or 1600 mg. The study involves triple masking, meaning that participants, investigators, and those assessing outcomes will not know which treatment is being given. The treatments will be administered during an approximately one-month inpatient admission period. During the study, participants will undergo assessments nine times to measure the reinforcing effects of cocaine while receiving the assigned treatment. Medical and psychiatric health will be monitored, including ECG readings by a cardiologist. Researchers will track how pentoxifylline affects cocaine's impact and monitor participants for safety. The study duration includes the inpatient stay and close observation throughout this month-long period.
CONDITIONS
Brief Title
Cocaine and Pentoxifylline (BED IN 47)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to speak and read English
- Not seeking treatment for drug use at the time of the study
- Female or male between 18 and 55 years old
- Recent smoked or intravenous cocaine use verified by positive urine test and meeting DSM-5 criteria for cocaine use disorder
- Medically and psychiatrically healthy except for cocaine use disorder
- Normal ECG reading by a cardiologist
- Females using effective birth control and not pregnant or breastfeeding
- No known allergies or contraindications to pentoxifylline
You will not qualify if you...
- Unable to speak or read English
- Seeking treatment for drug use
- Younger than 18 or older than 55 years
- No recent smoked or intravenous cocaine use and no DSM-5 diagnosis of cocaine use disorder
- Medically or psychiatrically unhealthy
- ECG outside normal limits
- Females not using effective birth control or who are pregnant or breastfeeding
- Allergies or contraindications to pentoxifylline
- History of head trauma, seizures, CNS tumors, use of medications lowering seizure threshold, or family history of seizures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month
Participants receive daily oral doses of placebo or pentoxifylline at two different dose levels during an approximately 1 month inpatient admission. The effects of cocaine and pentoxifylline are studied.
9 visits during inpatient admission
Trial Site Locations
Total: 1 location
1
Psychopharmacology of Addiction Laboratory
Lexington, Kentucky, United States, 40507
Actively Recruiting
Research Team
W
William W Stoops, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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