Cocaine and Pentoxifylline (BED IN 47)
Purpose
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.
Condition
- Cocaine Use Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
Subjects will be treated daily with an oral placebo. |
|
|
Experimental Pentoxifylline Dose 1 |
Subjects will be treated daily with oral pentoxifylline (1200 mg). |
|
|
Experimental Pentoxifylline Dose 2 |
Subjects will be treated daily with oral pentoxifylline (1600 mg). |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Psychopharmacology of Addiction Laboratory
Lexington, Kentucky 40507
Lexington, Kentucky 40507
More Details
- NCT ID
- NCT07086794
- Status
- Recruiting
- Sponsor
- William Stoops