Trial Outcomes & Findings for Brain Function and Structure in Cocaine Dependence (NCT NCT02080832)

Results Overview

Number of benzoylecgonine negative urines divided by the total number of urines collected

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

8 weeks of treatment

Results posted on

2017-12-26

Participant Flow

For some consented participants, the imaging scan (MRI) quality was not sufficient to include those participants in the outcome analysis. These participants are captured by the"excluded from analysis by MRI" category. fMRI data was only analyzed from participants who underwent MRI scans at UT Houston which can't be combined with MRI scans at VCU.

Participant milestones

Participant milestones
Measure	Medication Citalopram (20mg Dose) Citalopram (20mg dose) Citalopram: 20 mg daily for 8 weeks	Placebo Placebo: Placebo daily for 8 weeks	Medication Citalopram (40mg Dose) Citalopram (40mg dose) 40mg daily for 8 weeks
Overall Study STARTED	15	17	22
Overall Study COMPLETED	6	5	6
Overall Study NOT COMPLETED	9	12	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Medication Citalopram (20mg Dose) Citalopram (20mg dose) Citalopram: 20 mg daily for 8 weeks	Placebo Placebo: Placebo daily for 8 weeks	Medication Citalopram (40mg Dose) Citalopram (40mg dose) 40mg daily for 8 weeks
Overall Study Excluded from analysis by MRI	9	10	14
Overall Study Lost to Follow-up	0	2	2

Baseline Characteristics

Brain Function and Structure in Cocaine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medication Citalopram 20mg n=15 Participants Citalopram (20mg dose) Citalopram: 20 mg daily for 8 weeks	Placebo n=17 Participants Placebo: Placebo daily for 8 weeks	Medication Citalopram 40mg n=22 Participants Citalopram (40mg dose) 40mg daily for 8 weeks	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	17 Participants n=7 Participants	22 Participants n=5 Participants	54 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	45 Participants n=4 Participants
Race/Ethnicity, Customized African American	12 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants	43 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States	15 participants n=5 Participants	17 participants n=7 Participants	22 participants n=5 Participants	54 participants n=4 Participants

PRIMARY outcome

Timeframe: 8 weeks of treatment

Number of benzoylecgonine negative urines divided by the total number of urines collected

Outcome measures

Outcome measures
Measure	Medication (Citalopram 20mg) n=6 Participants Citalopram (20mg dose) Citalopram: 20 mg or 40 mg daily for 8 weeks	Placebo n=5 Participants Placebo: Placebo daily for 8 weeks	Medication (Citalopram 40mg) n=6 Participants Citalopram 40mg dose Citalopram: 20 mg or 40 mg daily for 8 weeks
Cocaine Use/Treatment Effectiveness Score (TES)	6.6 percentage of negative urines	8.3 percentage of negative urines	29 percentage of negative urines

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score.

Outcome measures

Outcome measures
Measure	Medication (Citalopram 20mg) n=13 Participants Citalopram (20mg dose) Citalopram: 20 mg or 40 mg daily for 8 weeks	Placebo n=4 Participants Placebo: Placebo daily for 8 weeks	Medication (Citalopram 40mg) Citalopram 40mg dose Citalopram: 20 mg or 40 mg daily for 8 weeks
fMRI Brain Activation in Right Inferior Frontal Gyrus	83 Percent of significant voxels in cluster	0 Percent of significant voxels in cluster	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score.

Outcome measures

Outcome measures
Measure	Medication (Citalopram 20mg) n=13 Participants Citalopram (20mg dose) Citalopram: 20 mg or 40 mg daily for 8 weeks	Placebo n=4 Participants Placebo: Placebo daily for 8 weeks	Medication (Citalopram 40mg) Citalopram 40mg dose Citalopram: 20 mg or 40 mg daily for 8 weeks
fMRI Brain Activation in Right Precentral Gyrus	9 percent of significant voxels in cluster	0 percent of significant voxels in cluster	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score.

Outcome measures

Outcome measures
Measure	Medication (Citalopram 20mg) n=13 Participants Citalopram (20mg dose) Citalopram: 20 mg or 40 mg daily for 8 weeks	Placebo n=4 Participants Placebo: Placebo daily for 8 weeks	Medication (Citalopram 40mg) Citalopram 40mg dose Citalopram: 20 mg or 40 mg daily for 8 weeks
fMRI Brain Activation in Right Orlandic Operculum	8 percent of significant voxels in cluster	0 percent of significant voxels in cluster	—

Adverse Events

Medication (Citalopram 20mg)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Medication (Citalopram 40mg)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

F. Gerard Moeller, M.D.

VCU

Phone: 804-828-4134

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place