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Could not obtain additional funding to continue the research.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Pretreatment with Calcitriol | Active Comparator | To explore the effects of acute pre-treatment with Calcitriol on attempts to self-administer and ultimate number of infusions/boluses of cocaine, in experienced, non treatment-seeking users of the drug |
|
| Acute Pretreatment with Placebo | Placebo Comparator | To explore the effects of acute pre-treatment with placebo on attempts to self-administer and ultimate number of infusions/boluses of cocaine, in experienced, non treatment-seeking users of the drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcitriol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cocaine Self Administration Attempts | Number of attempts to self administer cocaine will be analyzed. | 90 minutes |
| Cocaine Self Administration Infusions | Number of infusions of cocaine will be analyzed. | 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Probabilistic Selection Task (PST) | The Probabilistic Selection Task (PST) is a computerized task that assesses the tendency to learn from positive versus negative outcomes. PST will be analyzed using linear mixed models with treatment and time included as a within subjects variable. | 15 minutes |
| Probabilistic Reward Task (PRT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Potenza, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | United States |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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| Placebo | Other | 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. |
|
The Probabilistic Reward Task (PRT) is a computerized task that uses an asymmetric reinforcement schedule to produce a response bias towards the more frequently rewarded of two possible stimuli. PRT will be analyzed using linear mixed models with treatment and time included as a within subjects variable. |
| 15 minutes |
| Subjective Effects of Cocaine / Visual Analog Scale (VAS) | During cocaine sessions, subjects will complete a series of self rated subjective effects measuring how they feel on cocaine, using a scale of 0 (not at all) to 10 (most ever). VAS ratings will focus on euphoria ("high") as a primary outcome, however, other positive, negative, psychomotor, and drug-craving ratings (e.g. good, bad, stimulated, paranoid, hungry, etc.) will be collected as well. Ratings are implemented on a touch-screen laptop computer and presented every 5 minutes, throughout the session | 150 minutes |
| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |