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Recruiting

NCT Number: NCT07086794

Cocaine and Pentoxifylline (BED IN 47)

This will be a human laboratory study evaluating the influence of pentoxifylline treatment on the effects of cocaine. Supported by and included in the Helping to End Addiction Long-term® (HEAL) Initiative.

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Psychopharmacology of Addiction Laboratory

Lexington, Kentucky, 40507, United States

Location status: Recruiting

Location contact

William W Stoops, PhD

CONTACT

[email protected]

859-257-5388

William W Stoops, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • unable to speak/read English,
  • seeking treatment for drug use,
  • under 18 years or over 55 years,
  • no recent smoked or intravenous cocaine use as indicated by benzoylecgonine negative urine and no DSM-5 diagnosis of CUD,
  • judged to be medically or psychiatrically unhealthy by study physicians at the time of screening,
  • ECG, read by a cardiologist, outside normal limits,
  • females not using an effective form of birth control or pregnant or breastfeeding,
  • contraindications or allergies to pentoxifylline, and
  • 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.

Treatment and study plan

Placebo

Drug

The effects of placebo will be determined.

Cocaine (IV)

Drug

The effects of IV Cocaine will be determined.

Pentoxifylline

Drug

The effects of pentoxifylline will be determined.

Primary outcomes

  1. Reinforcing Effects of Cocaine

    Time frame: 9 times over approximately 1 month inpatient admission

    Number of Times Subjects Choose Cocaine (Maximum of 5 Choices) Over Money

Study contacts

Contact information is provided by the study sponsor or research team.

William W Stoops, PhD

CONTACT

[email protected]

859-257-5388

Sponsors and collaborators

Lead sponsor

William Stoops

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 25, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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