Cocaine Use DisorderEarly Phase 1NCT07086794
Cocaine and Pentoxifylline (BED IN 47)
A Early Phase 1 study testing Cocaine (IV) and Pentoxifylline in people with Cocaine Use Disorder, run by William Stoops at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Cocaine (IV) and Pentoxifylline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2025to 28 Feb 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Psychopharmacology of Addiction Laboratory
Lexington, Kentucky, 40507
William W Stoops, PhD, 859-257-5388, william.stoops@uky.edu
William W Stoops, PhD
About this study
Official title: Targeting Immune Inflammation in Cocaine Use Disorder: A Human Laboratory Study With Pentoxifylline
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
- Being tested
- Placebo, Cocaine (IV), Pentoxifylline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
The effects of placebo will be determined.
Cocaine (IV)Drug
The effects of IV Cocaine will be determined.
PentoxifyllineDrug
The effects of pentoxifylline will be determined.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will be treated daily with an oral placebo. Receives: Drug: Placebo |
| Pentoxifylline Dose 1 | Experimental | Subjects will be treated daily with oral pentoxifylline (1200 mg). Receives: Drug: Placebo; Drug: Cocaine (IV); Drug: Pentoxifylline |
| Pentoxifylline Dose 2 | Experimental | Subjects will be treated daily with oral pentoxifylline (1600 mg). Receives: Drug: Placebo; Drug: Cocaine (IV); Drug: Pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinforcing Effects of Cocaine
Number of Times Subjects Choose Cocaine (Maximum of 5 Choices) Over Money
Measured: 9 times over approximately 1 month inpatient admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start10 Nov 2025
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- William Stoops
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, William Stoops, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086794
- Sponsor's protocol ID
- 104811
- Other IDs
- R01DA063069
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Immune Inflammation in Cocaine Use Disorder: A Human Laboratory Study With Pentoxifylline
- ClinicalTrials.gov ID
- NCT07086794
- Acronym / sponsor ID
- 104811
- Conditions
- Cocaine Use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- William StoopsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSubjects will be treated daily with an oral placebo. |
| Pentoxifylline Dose 1 | Experimental | Drug: Placebo, Drug: Cocaine (IV), Drug: PentoxifyllineSubjects will be treated daily with oral pentoxifylline (1200 mg). |
| Pentoxifylline Dose 2 | Experimental | Drug: Placebo, Drug: Cocaine (IV), Drug: PentoxifyllineSubjects will be treated daily with oral pentoxifylline (1600 mg). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThe effects of placebo will be determined. | Drug | Pentoxifylline Dose 1, Pentoxifylline Dose 2, Placebo |
| Cocaine (IV)The effects of IV Cocaine will be determined. | Drug | Pentoxifylline Dose 1, Pentoxifylline Dose 2 |
| PentoxifyllineThe effects of pentoxifylline will be determined. | Drug | Pentoxifylline Dose 1, Pentoxifylline Dose 2 |
Primary outcome
Reinforcing Effects of Cocaine
Time frame: 9 times over approximately 1 month inpatient admission
Number of Times Subjects Choose Cocaine (Maximum of 5 Choices) Over Money
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cocaine (IV) and Pentoxifylline in people with Cocaine Use Disorder, run by William Stoops at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William W Stoops, PhD (859-257-5388, william.stoops@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reinforcing Effects of Cocaine (time frame: 9 times over approximately 1 month inpatient admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.