Cocaine Use DisorderPhase 2NCT03430544
Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder
A Phase 2 study testing Cariprazine Oral Capsule [Vraylar] in people with Cocaine Use Disorder, run by Anna Rose Childress, Ph.D. at 1 site in United States.
Trial summary
This is a phase II, randomized, single-blind, placebo-controlled study to examine whether cariprazine (1.5 or 3 mg/d) 1) alters brain and/or behavioral responses to probes of reward and inhibition and 2) decreases cocaine use in individuals with cocaine use disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Cariprazine Oral Capsule [Vraylar]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2018to 4 Sep 2020
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An informed consent voluntarily signed and dated by the subject.
- Physically healthy males and females with cocaine use disorder.
- Ability to read at or above eighth grade level and speak, understand, and write in English.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Available for an inpatient stay, when applicable.
Who cannot join
- Certain psychological disorders that could put subjects at risk during participation in the study.
- Certain lifetime or current medical disorders or conditions that could put subjects at risk during participation in the study.
- Medical contraindications for MRI, when applicable.
- Has received medication that could interact adversely with cariprazine within the time of administration of study agent based on the study physician's guidance.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized, Single-blind, Placebo-controlled Phase II Study to Assess the Effects of Cariprazine on Brain and Behavior in Subjects With Cocaine Use Disorder
This is a phase II, randomized, single-blind, placebo-controlled study to examine whether cariprazine (1.5 or 3 mg/d) 1) alters brain and/or behavioral responses to probes of reward and inhibition and 2) decreases cocaine use in individuals with cocaine use disorder. Subjects will be tested as inpatients during fMRI sessions. After the 2-week inpatient/medication induction phase, study medication will continue for 8 outpatient weeks, during which time cocaine use will be tracked. Subjects will be monitored during a 4-wk followup phase thereafter.
- Conditions
- Cocaine Use Disorder
- Being tested
- Cariprazine Oral Capsule [Vraylar], Placebo oral capsule
- Keywords
- cariprazine, fMRI, D3 receptor, cocaine use disorder, urine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cariprazine Oral Capsule [Vraylar]Drug
Cariprazine Groups (1.5 or 3mg/d): Cariprazine (VRAYLAR) capsules will be administered orally, once per day. Subjects in the 1.5mg group will receive 1 VRAYLAR capsule containing 1.5 mg cariprazine each day that study drug is administered. Subjects in the 3 mg group will be gradually titrated up to full dose: they will receive 1 VRAYLAR capsule containing 1.5mg cariprazine on the first and second days that study drug is administered and will receive 1 VRAYLAR capsule containing 3mg cariprazine each day for the rest of the medication period. The study medication period begins during the inpatient/induction phase and ends on the last day of outpatient treatment week 8 (approx. 10 weeks total). All VRAYLAR capsules will be over-encapsulated by the University of Pennsylvania Investigational Drug Services (IDS).
Placebo oral capsuleDrug
PLACEBO Group: Visually identical placebo capsules will be supplied by the University of Pennsylvania Investigational Drug Service, with a dosing regimen matching the cariprazine groups.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
| 1.5 mg/d cariprazine | Experimental | Not described Receives: Drug: Cariprazine Oral Capsule [Vraylar] |
| 3.0 mg/d cariprazine | Experimental | Not described Receives: Drug: Cariprazine Oral Capsule [Vraylar] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary fMRI outcome measure - BOLD signal change during visual cocaine vs. neutral cues.
The primary fMRI outcome is the extracted BOLD signal change during visual stimuli reminiscent of cocaine (i.e., cocaine cues) in an a priori circuit-level ROI.
Measured: Collected during fMRI scan 1, which takes place approximately 12-13 days after subject enrollment.
Primary clinical outcome measure - percentage of urines cocaine-positive or missing during outpatient phase.
The primary clinical outcome is percentage of urines cocaine-positive or missing (assessed by urines positive for benzoylecgonine (BE), a metabolite of cocaine) throughout the outpatient treatment phase [Urines are counted as BE-positive if BE exceeds 300 ng/ml or if they are missing (no sample provided for a time point)].
Measured: Urines are collected 3x per week during the 8 week outpatient phase.
Secondary outcomes (5)
Secondary fMRI outcome measure - BOLD signal change during attempted inhibition of cue-triggered drug craving.
The secondary fMRI outcome is the extracted BOLD signal change during attempted inhibition of cue-triggered drug craving in an a priori ROI .
Measured: Collected during fMRI scan 2, which takes place approximately 13-14 days after subject enrollment.
Attentional bias scores
Attentional bias scores derived from reaction time (msec) during attentional bias task
Measured: Completed on approximately day 14-15 after subject enrollment.
Affective bias scores
Affective bias scores derived from reaction time (msec) during affective bias task
Measured: Completed on approximately day 14-15 after subject enrollment.
Balloon Analogue Risk Task scores
# of average adjusted pumps on BART
Measured: Completed on approximately day 14-15 after subject enrollment.
Go-NoGo Task scores
# of errors of commission
Measured: Completed on approximately day 14-15 after subject enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start4 Apr 2018
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Why it stopped: Low recruitment in final grant year, halted on-site research due to COVID-19 during NCE year.
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.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Rose Childress, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Anna Rose Childress, Ph.D., University of Pennsylvania
- Investigators
- Anna Rose Childress, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430544
- Sponsor's protocol ID
- 828585
- Status last verified
- Sep 2020
- First submitted
- 29 Jan 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Placebo-controlled Phase II Study to Assess the Effects of Cariprazine on Brain and Behavior in Subjects With Cocaine Use Disorder
- ClinicalTrials.gov ID
- NCT03430544
- Acronym / sponsor ID
- 828585
- Conditions
- Cocaine Use Disorder
- Keywords
- cariprazine, fMRI, D3 receptor, cocaine use disorder, urine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment in final grant year, halted on-site research due to COVID-19 during NCE year.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Anna Rose Childress, Ph.D.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 13 Feb 2018 (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 is a phase II, randomized, single-blind, placebo-controlled study to examine whether cariprazine (1.5 or 3 mg/d) 1) alters brain and/or behavioral responses to probes of reward and inhibition and 2) decreases cocaine use in individuals with cocaine use disorder. Subjects will be tested as inpatients during fMRI sessions. After the 2-week inpatient/medication induction phase, study medication will continue for 8 outpatient weeks, during which time cocaine use will be tracked. Subjects will be monitored during a 4-wk followup phase thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral capsule |
| 1.5 mg/d cariprazine | Experimental | Drug: Cariprazine Oral Capsule [Vraylar] |
| 3.0 mg/d cariprazine | Experimental | Drug: Cariprazine Oral Capsule [Vraylar] |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- An informed consent voluntarily signed and dated by the subject.
- Physically healthy males and females with cocaine use disorder.
- Ability to read at or above eighth grade level and speak, understand, and write in English.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Available for an inpatient stay, when applicable.
Key exclusion criteria (4 listed)
- Certain psychological disorders that could put subjects at risk during participation in the study.
- Certain lifetime or current medical disorders or conditions that could put subjects at risk during participation in the study.
- Medical contraindications for MRI, when applicable.
- Has received medication that could interact adversely with cariprazine within the time of administration of study agent based on the study physician's guidance.
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 |
|---|---|---|
| Cariprazine Oral Capsule [Vraylar]Cariprazine Groups (1.5 or 3mg/d): Cariprazine (VRAYLAR) capsules will be administered orally, once per day. Subjects in the 1.5mg group will receive 1 VRAYLAR capsule containing 1.5 mg cariprazine each day that study drug is administered. Subjects in the 3 mg group will be gradually titrated up to full dose: they will receive 1 VRAYLAR capsule containing 1.5mg cariprazine on the first and second days that study drug is administered and will receive 1 VRAYLAR capsule containing 3mg cariprazine each day for the rest of the medication period. The study medication period begins during the inpatient/induction phase and ends on the last day of outpatient treatment week 8 (approx. 10 weeks total). All VRAYLAR capsules will be over-encapsulated by the University of Pennsylvania Investigational Drug Services (IDS). | Drug | 1.5 mg/d cariprazine, 3.0 mg/d cariprazine |
| Placebo oral capsulePLACEBO Group: Visually identical placebo capsules will be supplied by the University of Pennsylvania Investigational Drug Service, with a dosing regimen matching the cariprazine groups. | Drug | Placebo |
Primary outcome
Primary fMRI outcome measure - BOLD signal change during visual cocaine vs. neutral cues.
Time frame: Collected during fMRI scan 1, which takes place approximately 12-13 days after subject enrollment.
The primary fMRI outcome is the extracted BOLD signal change during visual stimuli reminiscent of cocaine (i.e., cocaine cues) in an a priori circuit-level ROI.
Primary clinical outcome measure - percentage of urines cocaine-positive or missing during outpatient phase.
Time frame: Urines are collected 3x per week during the 8 week outpatient phase.
The primary clinical outcome is percentage of urines cocaine-positive or missing (assessed by urines positive for benzoylecgonine (BE), a metabolite of cocaine) throughout the outpatient treatment phase [Urines are counted as BE-positive if BE exceeds 300 ng/ml or if they are missing (no sample provided for a time point)].
5 secondary outcomes
Secondary fMRI outcome measure - BOLD signal change during attempted inhibition of cue-triggered drug craving.
Time frame: Collected during fMRI scan 2, which takes place approximately 13-14 days after subject enrollment.
Attentional bias scores
Time frame: Completed on approximately day 14-15 after subject enrollment.
Affective bias scores
Time frame: Completed on approximately day 14-15 after subject enrollment.
Balloon Analogue Risk Task scores
Time frame: Completed on approximately day 14-15 after subject enrollment.
Go-NoGo Task scores
Time frame: Completed on approximately day 14-15 after subject enrollment.
Results and safety
The study was stopped early (reason given: Low recruitment in final grant year, halted on-site research due to COVID-19 during NCE year.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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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.
Anna Rose Childress, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cariprazine Oral Capsule [Vraylar] in people with Cocaine Use Disorder, run by Anna Rose Childress, Ph.D. 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 5 inclusion and 4 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 9 Sep 2020. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Low recruitment in final grant year, halted on-site research due to COVID-19 during NCE year.). 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?
Primary fMRI outcome measure - BOLD signal change during visual cocaine vs. neutral cues. (time frame: Collected during fMRI scan 1, which takes place approximately 12-13 days after subject enrollment.). 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 9 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.