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Recruiting NCT07086794

Cocaine and Pentoxifylline (BED IN 47)

Early Phase I Interventional Cocaine Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, Cocaine (IV), Pentoxifylline.
Who it may be relevant to
Registry conditions: Cocaine Use Disorder. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Targeting Immune Inflammation in Cocaine Use Disorder: A Human Laboratory Study With Pentoxifylline

Overview

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.

Interventions

  • Drug Placebo
    The effects of placebo will be determined.
  • Drug Cocaine (IV)
    The effects of IV Cocaine will be determined.
  • Drug Pentoxifylline
    The effects of pentoxifylline will be determined.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Psychopharmacology of Addiction Laboratory — Lexington

Identifiers

NCT: NCT07086794 · 104811 · R01DA063069

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗