Recruiting
Early Phase 1

Pentoxifylline

Sponsor:

William Stoops

Code:

NCT07086794

Conditions

Cocaine Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Placebo

Cocaine (IV)

Pentoxifylline

Study Details

Brief summary:

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.

Conditions

Cocaine Use Disorder

Study ID

NCT07086794

Start date

Nov 10, 2025

Status verified date

Jun, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Subjects will be treated daily with an oral placebo.

experimental: Pentoxifylline Dose 1

Subjects will be treated daily with oral pentoxifylline (1200 mg).

experimental: Pentoxifylline Dose 2

Subjects will be treated daily with oral pentoxifylline (1600 mg).

Interventions

Placebo

The effects of placebo will be determined.

Cocaine (IV)

The effects of IV Cocaine will be determined.

Pentoxifylline

The effects of pentoxifylline will be determined.

Primary outcome measure

  • Reinforcing Effects of Cocaine [ Time Frame: 9 times over approximately 1 month inpatient admission ]

Central Contacts and Locations

Central contacts

Locations

Psychopharmacology of Addiction Laboratory

Recruiting

Lexington, Kentucky, United States, 40507

Contacts

Principal Investigator:

William W Stoops, PhD

More Information

Sponsor

William Stoops

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by William Stoops on 2026-06-08.