Pentoxifylline for Cocaine Use

Overseen By William W Stoops, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: William Stoops

Must not be taking: Seizure threshold-lowering drugs

Disqualifiers: Seizures, CNS tumors, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a drug called pentoxifylline affects the experience of using cocaine. Researchers aim to determine if pentoxifylline can alter cocaine's effects in regular users. Participants will join one of three groups: two will receive different doses of pentoxifylline, and one will receive a placebo (a pill with no active drug). Ideal candidates for this trial have recently used cocaine, meet the diagnostic criteria for cocaine use disorder (CUD), and are not currently seeking treatment for drug use. As an Early Phase 1 trial, this research focuses on understanding how pentoxifylline works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking medications that lower the seizure threshold, you may not be eligible to participate.

Is there any evidence suggesting that pentoxifylline is likely to be safe for humans?

Research has shown that pentoxifylline is generally safe and has been used for other health issues. This medication often improves blood flow in people with circulation problems. Although pentoxifylline has not been proven to treat cocaine use disorder, its safety is well-known.

In other cases, patients usually tolerate pentoxifylline well. Common side effects might include dizziness, headache, or nausea, but serious side effects are rare. Since this is an early trial, the main focus will be on the drug's safety for people who use cocaine. While testing for cocaine use is just beginning, there is already some understanding of its safety from other uses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cocaine use?

Researchers are excited about pentoxifylline as a treatment for cocaine use because it offers a new approach by potentially reducing inflammation and improving blood flow in the brain, which could help in managing addiction. Unlike current treatments like behavioral therapies and medications such as disulfiram or modafinil, pentoxifylline targets the vascular system, which is a novel angle for addressing cocaine addiction. Additionally, the study explores two different dosages, 1200 mg and 1600 mg, which could provide insights into optimizing its effectiveness and safety.

What evidence suggests that pentoxifylline might be an effective treatment for cocaine use?

Research suggests that pentoxifylline might help reduce cocaine use and cravings. Some studies have shown a noticeable decrease in cocaine use among people taking pentoxifylline, although these results were not always statistically significant. While the evidence isn't definitive, a trend indicates that pentoxifylline could assist those struggling with cocaine addiction. Participants in this trial will receive either a daily dose of pentoxifylline at 1200 mg, a higher dose at 1600 mg, or a placebo. Researchers believe pentoxifylline works by improving blood flow, which might help lessen the desire for cocaine. However, more research is needed to fully understand its effectiveness. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-55 who have recently used cocaine but aren't seeking drug treatment. Participants must meet the criteria for Cocaine Use Disorder, be medically and psychiatrically healthy except for CUD, have a normal ECG, and if female, not be pregnant or breastfeeding and use birth control.

Inclusion Criteria

Able to speak/read English

Not seeking treatment for drug use at the time of the study

Recent smoked or intravenous cocaine use verified by benzoylecgonine positive urine, as well as fulfillment of DSM-5 diagnostic criteria for CUD

Exclusion Criteria

Unable to speak/read English

Seeking treatment for drug use

No recent smoked or intravenous cocaine use as indicated by benzoylecgonine negative urine and no DSM-5 diagnosis of CUD

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral pentoxifylline or placebo during inpatient admission

4 weeks

Daily visits (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pentoxifylline

Trial Overview The study tests how pentoxifylline affects the body's response to cocaine. It includes people given IV cocaine, others receiving pentoxifylline (an anti-inflammatory medication), and some getting a placebo. The goal is to see if pentoxifylline can reduce the effects of cocaine as part of the HEAL Initiative.

How Is the Trial Designed?

Group I: Pentoxifylline Dose 2 Experimental Treatment 3 Interventions

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

Group II: Pentoxifylline Dose 1 Experimental Treatment 3 Interventions

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

Group III: Placebo Placebo Group 1 Intervention

Subjects will be treated daily with an oral placebo.

Who Is Running the Clinical Trial?

William Stoops

Lead Sponsor

Trials

9

Recruited

240+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15730346/

Efficacy screening trials of paroxetine, pentoxifylline, riluzole ... Significant within-group reductions in reported cocaine use and craving were found for all treatment groups, but none of the active medications were superior to ...

2. patlynk.com patlynk.com/trial/NCT07086794

Pentoxifylline for Cocaine Use Disorder This study aims to explore how a medication called pentoxifylline might affect people who use cocaine. Cocaine use disorder is a condition where individuals ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/j.1360-0443.2005.00985.x

Efficacy screening trials of paroxetine, pentoxifylline ... Significant within-group reductions in reported cocaine use and craving were found for all treatment groups, but none of the active medications ...

4. researchgate.net researchgate.net/publication/8004040_Efficacy_screening_trials_of_paroxetine_pentoxifylline_riluzole_pramipexole_and_venlafaxine_in_cocaine_dependence

Efficacy screening trials of paroxetine, pentoxifylline ... Use of the related compound pentoxifylline resulted in a non-significant trend toward a decrease in cocaine abuse in addicted individuals; ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9688748/

Pharmacological Treatments for Cocaine Craving A total of 84 studies evaluated both craving and cocaine use as outcomes, 76% of them (64) presented a direct correlation between craving and cocaine use after ...

6. withpower.com withpower.com/trial/early-phase-1-methamphetamine-use-disorder-10-2025-b8182

Pentoxifylline for Cocaine Use · Info for Participants What is the purpose of this trial? This will be a human laboratory study evaluating the influence of pentoxifylline treatment on the effects of cocaine.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/j.1360-0443.2005.00985.x

Efficacy screening trials of paroxetine, pentoxifylline ... This study does not support the use of paroxetine, pentoxifylline, riluzole, venlafaxine or pramipexole for the treatment of cocaine dependence.