Cocaine and Pentoxifylline (BED IN 47)

Not Applicable

Not yet recruiting

• Conditions: Methamphetamine Use Disorder
• Interventions: Drug: Placebo; Drug: Cocaine (IV); Drug: Pentoxifylline

• Registration Number: NCT07086794
• Lead Sponsor: William Stoops

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-18
• Study First Submitted QC: 2025-07-18
• Study First Posted: 2025-07-25
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-13
• Last Update Posted: 2025-08-19
• Study Start: 2025-11-01
• Primary Completion: 2028-02-28
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pentoxifylline Dose 1	Cocaine (IV)	Subjects will be treated daily with oral pentoxifylline (1200 mg).
Pentoxifylline Dose 2	Cocaine (IV)	Subjects will be treated daily with oral pentoxifylline (1600 mg).
Placebo	Placebo	Subjects will be treated daily with an oral placebo.
Pentoxifylline Dose 1	Pentoxifylline	Subjects will be treated daily with oral pentoxifylline (1200 mg).
Pentoxifylline Dose 1	Placebo	Subjects will be treated daily with oral pentoxifylline (1200 mg).
Pentoxifylline Dose 2	Placebo	Subjects will be treated daily with oral pentoxifylline (1600 mg).
Pentoxifylline Dose 2	Pentoxifylline	Subjects will be treated daily with oral pentoxifylline (1600 mg).

Primary Outcome Measures

Name	Time	Method
Reinforcing Effects of Methamphetamine	9 times over approximately 1 month inpatient admission	Number of Times Subjects Choose Methamphetamine (Maximum of 5 Choices) Over Money

Trial Locations

Locations (1)

Psychopharmacology of Addiction Laboratory; 🇺🇸 Lexington, Kentucky, United States