Cocaine and Pentoxifylline (BED IN 47)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-10

Study Completion Date

2028-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Cocaine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Intervention Type DRUG

The effects of pentoxifylline will be determined.

Interventions

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Placebo

The effects of placebo will be determined.

Intervention Type DRUG

Cocaine (IV)

The effects of IV Cocaine will be determined.

Intervention Type DRUG

Pentoxifylline

The effects of pentoxifylline will be determined.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes