Clinical trial NCT04826133: Vitamin D and Cocaine Administration
Official title: Testing Restoring Effects of Vitamin D on the Dopamine System: A Human Laboratory Study Among Cocaine Users.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Cocaine Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 4
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Age 30-55 years
* Voluntary, written, informed consent
* Physically healthy by medical history, physical, neurological, ECG and laboratory examinations
* DSM-5 criteria for at least moderate Cocaine Use Disorder
* Recent street cocaine use in excess of quantities used in the current study
* Intravenous and/or smoked (crack/ freebase) use
* Positive urine toxicology screen for cocaine
* Laboratory evidence of vitamin D sufficiency (i.e., 25(OH)-vitamin D3 level ≥ 20/mg)
* For females, a negative serum pregnancy (HCG) test at screening and admission, and a negative urine pregnancy test (HCG) on cocaine administration days.

Exclusion Criteria:

* A history of other substance dependence (except for nicotine). Positive urine toxicology for cannabis is accepted for the study unless there is evidence for dependence per Structured Clinical Interview for DSM-5 (SCID) interview. Positive urine toxicology for other drugs at screening will be repeated. If positive again and/or positive at admission, subjects will be excluded
* \< 1 year of cocaine abuse/dependence
* A primary DSM-5 Axis I major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) unrelated to cocaine as determined by the SCID-5
* Medical comorbidities including serum calcium ( \> 10.5 mg/dl, serum phosphorus \> 4.2 mg/dl), hyperparathyroidism, kidney disease (e.g., Serum creatinine \> 1.3 mg/dl)
* A history of significant and uncontrolled medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular, seizures, traumatic brain injury) illness
* A history of seizures
* Current use of psychotropic/potentially psychoactive medications or medications that can have drug drug interactions with calcitriol, including over the counter Vitamin D products, thiazide diuretics, and calcium supplements, etc, as referenced in the package insert for calcitriol
* Seeking treatment for drug abuse/dependence
* Hypersensitivity to calcitriol
* For females, physical or laboratory (HCG) evidence of pregnancy.

Primary outcomes:
measure: Cocaine Self Administration Attempts
timeFrame: 90 minutes
measure: Cocaine Self Administration Infusions
timeFrame: 90 minutes
Secondary outcomes:
measure: Probabilistic Selection Task (PST)
timeFrame: 15 minutes
measure: Probabilistic Reward Task (PRT)
timeFrame: 15 minutes
measure: Subjective Effects of Cocaine / Visual Analog Scale (VAS)
timeFrame: 150 minutes
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Marc Potenza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: