Status:
TERMINATED
Vitamin D and Cocaine Administration
Lead Sponsor:
Yale University
Conditions:
Cocaine Use Disorder
Eligibility:
All Genders
30-55 years
Phase:
EARLY_PHASE1
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 ultimat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04826133
Start Date
March 27 2019
End Date
January 17 2020
Last Update
August 14 2023
Active Locations (1)
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1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519