Trial Outcomes & Findings for Stress and Medication Effects on Cocaine Cue Reactivity (NCT NCT00613015)

Results Overview

Participants were randomized to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to participate in the TRIER social stress task or to read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for 2 minutes and cocaine cues for 2 minutes. Immediately following the cocaine cue exposure, participants were asked to rate cocaine craving on a 10-point Likert scale, with 0 being Not at All and 10 being Extremely.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

109 participants

Primary outcome timeframe

Post Trier social stress task + Cocaine Cue 2:30 pm

Results posted on

2018-06-04

Participant Flow

Participants were recruited between April 2008 and May 2012. Participants were primarily recruited through newspaper and television advertisements and respondent driven sampling. All study procedures took place at the Medical University of South Carolina.

50 participants were enrolled and dropped for unknown reason. 22 participants were enrolled but failed the urine drug screen. 2 participants were unable to complete due to obtaining employment. 2 participants completed procedures, but were later discovered to have bipolar disorder. Their data was not used.

Participant milestones

Participant milestones
Measure	Modafinil/Stress Participants received Modafinil for three days and completed a TRIER social stress task on the third day.	Modafinil/No Stress Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.	Guanfacine/Stress Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.	Guanfacine/No Stress Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.	Placebo/Stress Participants received placebo for 3 days and completed the TRIER social stress task on the third day.	Placebo/No Stress Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
Overall Study STARTED	13	12	26	24	15	19
Overall Study COMPLETED	13	11	23	21	13	16
Overall Study NOT COMPLETED	0	1	3	3	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Modafinil/Stress Participants received Modafinil for three days and completed a TRIER social stress task on the third day.	Modafinil/No Stress Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.	Guanfacine/Stress Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.	Guanfacine/No Stress Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.	Placebo/Stress Participants received placebo for 3 days and completed the TRIER social stress task on the third day.	Placebo/No Stress Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
Overall Study Lost to Follow-up	0	1	3	3	2	3

Baseline Characteristics

Stress and Medication Effects on Cocaine Cue Reactivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Modafinil/Stress n=13 Participants Participants received Modafinil for three days and completed a TRIER social stress task on the third day.	Modafinil/No Stress n=12 Participants Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.	Guanfacine/Stress n=26 Participants Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.	Guanfacine/No Stress n=24 Participants Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.	Placebo/Stress n=15 Participants Participants received placebo for 3 days and completed the TRIER social stress task on the third day.	Placebo/No Stress n=19 Participants Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.	Total n=109 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	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants	24 Participants n=4 Participants	15 Participants n=21 Participants	19 Participants n=8 Participants	109 Participants n=8 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	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Continuous	42.46 years STANDARD_DEVIATION 8.03 • n=5 Participants	38.5 years STANDARD_DEVIATION 10.49 • n=7 Participants	41 years STANDARD_DEVIATION 10.05 • n=5 Participants	40.92 years STANDARD_DEVIATION 9.55 • n=4 Participants	40.2 years STANDARD_DEVIATION 9.13 • n=21 Participants	44 years STANDARD_DEVIATION 8.6 • n=8 Participants	41.41 years STANDARD_DEVIATION 9.28 • n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	19 Participants n=8 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants	20 Participants n=4 Participants	12 Participants n=21 Participants	14 Participants n=8 Participants	90 Participants n=8 Participants
Region of Enrollment United States	13 participants n=5 Participants	12 participants n=7 Participants	26 participants n=5 Participants	24 participants n=4 Participants	15 participants n=21 Participants	19 participants n=8 Participants	109 participants n=8 Participants

PRIMARY outcome

Timeframe: Post Trier social stress task + Cocaine Cue 2:30 pm

Participants were randomized to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to participate in the TRIER social stress task or to read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for 2 minutes and cocaine cues for 2 minutes. Immediately following the cocaine cue exposure, participants were asked to rate cocaine craving on a 10-point Likert scale, with 0 being Not at All and 10 being Extremely.

Outcome measures

Outcome measures
Measure	Modafinil/Stress n=13 Participants Participants received Modafinil for three days and completed a TRIER social stress task on the third day.	Modafinil/No Stress n=12 Participants Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.	Guanfacine/Stress n=26 Participants Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.	Guanfacine/No Stress n=24 Participants Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.	Placebo/Stress n=15 Participants Participants received placebo for 3 days and completed the TRIER social stress task on the third day.	Placebo/No Stress n=19 Participants Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
Cocaine Craving	3.08 units on a scale Standard Deviation 3.59	4.36 units on a scale Standard Deviation 2.84	1.54 units on a scale Standard Deviation 3.06	3.13 units on a scale Standard Deviation 3.49	1.8 units on a scale Standard Deviation 2.8	2.11 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: Immediately following trier + cocaine cue exposure

Participants were randomized to receive to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to complete a TRIER social stress task or read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for two minutes and control cues for two minutes. Immediately following exposure to the cocaine cue, saliva samples were collected to measure cortisol levels.