Not provided
Not provided
Not provided
Not provided
Not provided
Low recruitment in final grant year, halted on-site research due to COVID-19 during NCE year.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| 1.5 mg/d cariprazine | Experimental |
| |
| 3.0 mg/d cariprazine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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)]. | Urines are collected 3x per week during the 8 week outpatient phase. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 . | Collected during fMRI scan 2, which takes place approximately 13-14 days after subject enrollment. |
Not provided
Inclusion Criteria (limited):
Exclusion Criteria (limited):
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anna Rose Childress, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 17, 2022 | Dec 15, 2022 | 6 | ||
| Jun 27, 2023 |
| ID | Term |
|---|---|
| C533287 | cariprazine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo oral capsule | Drug | 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. |
|
| Attentional bias scores | Attentional bias scores derived from reaction time (msec) during attentional bias task | Completed on approximately day 14-15 after subject enrollment. |
| Affective bias scores | Affective bias scores derived from reaction time (msec) during affective bias task | Completed on approximately day 14-15 after subject enrollment. |
| Balloon Analogue Risk Task scores | # of average adjusted pumps on BART | Completed on approximately day 14-15 after subject enrollment. |
| Go-NoGo Task scores | # of errors of commission | Completed on approximately day 14-15 after subject enrollment. |
| Jul 18, 2023 |
| 7 |
| Dec 5, 2023 | Dec 22, 2023 | 8 |
| Feb 12, 2024 | Mar 11, 2024 | 9 |