Cocaine and Pentoxifylline (BED IN 47)

NCT07086794 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 104811R01DA063069
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Reinforcing Effects of Cocaine

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

  9 times over approximately 1 month inpatient admission

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects will be treated daily with an oral placebo.

Drug: Placebo

Pentoxifylline Dose 1

EXPERIMENTAL

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

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

Pentoxifylline Dose 2

EXPERIMENTAL

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

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

Interventions

Placebo DRUG

The effects of placebo will be determined.

Pentoxifylline Dose 1; Pentoxifylline Dose 2; Placebo

Cocaine (IV) DRUG

The effects of IV Cocaine will be determined.

Pentoxifylline Dose 1; Pentoxifylline Dose 2

Pentoxifylline DRUG

The effects of pentoxifylline will be determined.

Pentoxifylline Dose 1; Pentoxifylline Dose 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• William Stoops: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Psychopharmacology of Addiction Laboratory

Lexington, Kentucky, 40507, United States

RECRUITING

MeSH Terms

Interventions

Cocaine; Pentoxifylline

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

William W Stoops, PhD

CONTACT

859-257-5388; william.stoops@uky.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)