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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Psychopharmacology of Addiction Laboratory
  Lexington, Kentucky, United States Recruiting

Study contacts

• Study coordinator: William W Stoops, PhD
• Email: william.stoops@uky.edu
• Phone: 859-257-5388

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.