Cocaine and Pentoxifylline (BED IN 47)

William Stoops

Status and phase: Enrolling; Early Phase 1

Conditions: Cocaine Use Disorder

Treatments: Drug: Placebo; Drug: Pentoxifylline; Drug: Cocaine (IV)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07086794

104811

R01DA063069 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects will be treated daily with an oral placebo.

Treatment:

Drug: Placebo

Pentoxifylline Dose 1

Experimental group

Description:

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

Treatment:

Drug: Cocaine (IV)

Drug: Pentoxifylline

Drug: Placebo

Pentoxifylline Dose 2

Experimental group

Description:

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

Treatment:

Drug: Cocaine (IV)

Drug: Pentoxifylline

Drug: Placebo