Cocaine Use DisorderEarly Phase 1NCT04826133
Vitamin D and Cocaine Administration
A Early Phase 1 study testing Calcitriol in people with Cocaine Use Disorder, run by Yale University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Calcitriol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2019to 17 Jan 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
Official title: Testing Restoring Effects of Vitamin D on the Dopamine System: A Human Laboratory Study Among Cocaine Users.
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
- Being tested
- Calcitriol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
Also called 1,25-dihydroxyvitamin D3
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Calcitriol |
| 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Self Administration Attempts
Number of attempts to self administer cocaine will be analyzed.
Measured: 90 minutes
Cocaine Self Administration Infusions
Number of infusions of cocaine will be analyzed.
Measured: 90 minutes
Secondary outcomes (3)
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.
Measured: 15 minutes
Probabilistic Reward Task (PRT)
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.
Measured: 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
Measured: 150 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start27 Mar 2019
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Why it stopped: Could not obtain additional funding to continue the research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Potenza, Yale University
- Investigators
- Marc Potenza, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826133
- Sponsor's protocol ID
- 2000025367
- Status last verified
- Aug 2023
- First submitted
- 24 Mar 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Restoring Effects of Vitamin D on the Dopamine System: A Human Laboratory Study Among Cocaine Users.
- ClinicalTrials.gov ID
- NCT04826133
- Acronym / sponsor ID
- 2000025367
- Conditions
- Cocaine Use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Could not obtain additional funding to continue the research.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Pretreatment with Calcitriol | Active comparator | Drug: CalcitriolTo 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 | Other: PlaceboTo 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 |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalcitriolAlso: 1,25-dihydroxyvitamin D3Subjects 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. | Drug | Acute Pretreatment with Calcitriol |
| PlaceboSubjects 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. | Other | Acute Pretreatment with Placebo |
Primary outcome
Cocaine Self Administration Attempts
Time frame: 90 minutes
Number of attempts to self administer cocaine will be analyzed.
Cocaine Self Administration Infusions
Time frame: 90 minutes
Number of infusions of cocaine will be analyzed.
3 secondary outcomes
Probabilistic Selection Task (PST)
Time frame: 15 minutes
Probabilistic Reward Task (PRT)
Time frame: 15 minutes
Subjective Effects of Cocaine / Visual Analog Scale (VAS)
Time frame: 150 minutes
Results and safety
The study was stopped early (reason given: Could not obtain additional funding to continue the research.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Potenza, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Calcitriol in people with Cocaine Use Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Could not obtain additional funding to continue the research.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cocaine Self Administration Attempts (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.