See if pentoxifylline changes how cocaine affects adults with cocaine use disorder

Targeting Immune Inflammation in Cocaine Use Disorder: A Human Laboratory Study With Pentoxifylline

We will test whether taking pentoxifylline changes how cocaine affects adults with cocaine use disorder who are not currently seeking treatment.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: University of Kentucky (Academic / other)
• Locations: 1 site (Lexington, Kentucky)
• Trial ID: NCT07086794 on ClinicalTrials.gov

What this trial studies

This early-phase human laboratory trial will test whether oral pentoxifylline alters subjective, physiological, and behavioral responses to controlled intravenous cocaine in adults with cocaine use disorder. Eligible participants must have recent smoked or IV cocaine use confirmed by urine benzoylecgonine and meet DSM-5 criteria for CUD while being medically and psychiatrically stable; women must not be pregnant and must use effective contraception. Sessions involve administration of pentoxifylline or placebo followed by supervised IV cocaine to measure acute effects in a controlled setting. The work is supported by the HEAL Initiative and performed at the Psychopharmacology of Addiction Laboratory in Lexington, Kentucky.

Who should consider this trial

Good fit: Adults aged 18–55 who meet DSM-5 criteria for cocaine use disorder, have recent smoked or IV cocaine use confirmed by urine test, are medically and psychiatrically stable, are not seeking treatment, speak/read English, and (for women) are not pregnant and use effective birth control are the ideal candidates.

Not a fit: People outside the 18–55 age range, those without recent smoked or IV cocaine use, those actively seeking treatment, pregnant or breastfeeding women, or individuals with medical/psychiatric contraindications or allergies to pentoxifylline are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, pentoxifylline could reduce the rewarding or harmful effects of cocaine and inform development of new treatments for cocaine use disorder.

How similar studies have performed: This is a relatively novel application for pentoxifylline; while some preclinical and early human-lab work has explored anti-inflammatory and phosphodiesterase inhibitors for stimulant effects, strong clinical success for this approach has not been established.

Eligibility criteria

Inclusion Criteria:

1. able to speak/read English,
2. not seeking treatment for drug use at the time of the study,
3. female or male between the ages of 18 and 55 years,
4. recent smoked or intravenous cocaine use verified by benzoylecgonine positive urine, as well as fulfillment of DSM-5 diagnostic criteria for CUD,
5. judged to be medically and psychiatrically healthy by study physicians other than the diagnosis for CUD at the time of screening,
6. ECG, read by a cardiologist, within normal limits,
7. females using an effective form of birth control and not pregnant or breastfeeding and 8) no known contraindications or allergies to pentoxifylline.

Exclusion Criteria:

1. unable to speak/read English,
2. seeking treatment for drug use,
3. under 18 years or over 55 years,
4. no recent smoked or intravenous cocaine use as indicated by benzoylecgonine negative urine and no DSM-5 diagnosis of CUD,
5. judged to be medically or psychiatrically unhealthy by study physicians at the time of screening,
6. ECG, read by a cardiologist, outside normal limits,
7. females not using an effective form of birth control or pregnant or breastfeeding,
8. contraindications or allergies to pentoxifylline, and
9. Self-reported history of head trauma, seizure, CNS tumors, or use of concomitant medications that lower seizure threshold, or first-degree family history of seizures.

Where this trial is running

Lexington, Kentucky

• Psychopharmacology of Addiction Laboratory — Lexington, Kentucky, United States (Recruiting)

Study contacts

• Study coordinator: William W Stoops, PhD

Conditions Cocaine Use Disorder