Clinical trial NCT03430544: Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cocaine Use Disorder
Keywords: cariprazine
fMRI
D3 receptor
cocaine use disorder
urine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-02-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria (limited):

1. An informed consent voluntarily signed and dated by the subject.
2. Physically healthy males and females with cocaine use disorder.
3. Ability to read at or above eighth grade level and speak, understand, and write in English.
4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
5. Available for an inpatient stay, when applicable.

Exclusion Criteria (limited):

1. Certain psychological disorders that could put subjects at risk during participation in the study.
2. Certain lifetime or current medical disorders or conditions that could put subjects at risk during participation in the study.
3. Medical contraindications for MRI, when applicable.
4. Has received medication that could interact adversely with cariprazine within the time of administration of study agent based on the study physician's guidance.

Primary outcomes:
measure: Primary fMRI outcome measure - BOLD signal change during visual cocaine vs. neutral cues.
timeFrame: Collected during fMRI scan 1, which takes place approximately 12-13 days after subject enrollment.
measure: Primary clinical outcome measure - percentage of urines cocaine-positive or missing during outpatient phase.
timeFrame: Urines are collected 3x per week during the 8 week outpatient phase.
Secondary outcomes:
measure: Secondary fMRI outcome measure - BOLD signal change during attempted inhibition of cue-triggered drug craving.
timeFrame: Collected during fMRI scan 2, which takes place approximately 13-14 days after subject enrollment.
measure: Attentional bias scores
timeFrame: Completed on approximately day 14-15 after subject enrollment.
measure: Affective bias scores
timeFrame: Completed on approximately day 14-15 after subject enrollment.
measure: Balloon Analogue Risk Task scores
timeFrame: Completed on approximately day 14-15 after subject enrollment.
measure: Go-NoGo Task scores
timeFrame: Completed on approximately day 14-15 after subject enrollment.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Anna Rose Childress, PhD
role: PRINCIPAL_INVESTIGATOR
References: