NCT04826133

Vitamin D and Cocaine Administration

Testing Restoring Effects of Vitamin D on the Dopamine System: A Human Laboratory Study Among Cocaine Users.

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 30 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to explore the effects of acute pre-treatment with 1,25-dihydroxyvitamin D3 (calcitriol), as compared to placebo on the behavioral (e.g., attempts to self-administer and ultimate number of infusions/boluses of cocaine self-administered), neurocognitive (e.g., performance on computerized tests of reward related learning such as the probabilistic selection task or PST and probabilistic reward task or PRT), and subjective effects (e.g, computerized visual analog scale \[VAS\] ratings of euphoria/, craving, etc.) of cocaine in experienced, non-treatment seeking users of the drug.

Conditions

• Cocaine Use Disorder

Interventions

Type	Name	Description
DRUG	Calcitriol	Subjects will receive an oral administration of calcitriol (1,25-dihydroxyvitamin D3) 1.5 μg (three capsules of 0.5 μg each) at 9 pm, night before each cocaine session, and at 8 am, morning of each cocaine session. This dose of calcitriol is lower than doses safely administered in other human studies and for a duration of time shorter than doses safely administered in other trials. In addition, this dose has been already tested by our group, subject of a different grant application, and should be effective at enhancing stimulant's induced dopamine release, in comparison to placebo.
OTHER	Placebo	Subjects will receive an oral administration of three capsules of placebo at 9 pm the night before each cocaine session, and at 8 am, morning of each cocaine session.

Timeline

• Start date: 2019-03-27
• Primary completion: 2020-01-17
• Completion: 2020-01-17
• First posted: 2021-04-01
• Last updated: 2023-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study