Trial Outcomes & Findings for The Effect of Yohimbine on Cocaine Cue Reactivity (NCT NCT00535002)

Last Updated: 2017-06-07

Results Overview

Cocaine-dependent participants were pre-treated with either yohimbine or placebo provided subjective ratings of cocaine craving immediately following cocaine cue exposure. The scale used was the Within Sessions Ratings Scales (Childress AR, McLellan AT, O'Brien CP (1986) Conditioned responses in a methadone population. A comparison of laboratory, clinic, and natural settings. Journal of Substance Abuse Treatment 3:173-179.) Craving was rated on a scale of 0-10 with 0 being Not At All and 10 being Extremely.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

112 participants

Primary outcome timeframe

Post cocaine cue exposure

Results posted on

2017-06-07

Participant Flow

Cocaine-dependent and control males and females between the ages of 18 and 65 were recruited between July 2008 and July 2012. Participants were primarily recruited through newspaper advertisements, and study procedures were conducted in the Clinical Neuroscience Division and Clinical and Translational Research Center of MUSC.

A total of 400 people consented to study participation; 171 met study inclusion criteria. 115 people completed study procedures, and the data of 112 subjects was included for analysis. Data from two participants were excluded from analysis because it was discovered later that they did not meet eligibility requirements.

Participant milestones

Participant milestones
Measure	Cocaine Females, Yohimbine Then Placebo Cocaine-dependent females, Yohimbine then placebo	Cocaine Males, Yohimbine Then Placebo Cocaine-dependent males, Yohimbine then placebo	Control Females, Yohimbine Then Placebo Non-dependent females, Yohimbine then placebo	Control Males, Yohimbine Then Placebo Non-dependent males, Yohimbine then placebo	Cocaine Females, Placebo Then Yohimbine Cocaine females-dependent females, Placebo then yohimbine	Cocaine Males, Placebo Then Yohimbine Cocaine-dependent males, Placebo then Yohimbine	Control Females, Placebo Then Yohimbine Non-dependent females, placebo then yohimbine	Control Males, Placebo Then Yohimbine Non-dependent males, placebo then yohimbine
Overall Study STARTED	19	12	13	14	9	17	12	16
Overall Study COMPLETED	19	12	13	14	9	17	12	16
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Yohimbine on Cocaine Cue Reactivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cocaine Females, Yohimbine Then Placebo n=19 Participants Cocaine-dependent females, received yohimbine day 1, placebo day 2	Cocaine Females, Placebo Then Yohimbine n=9 Participants Cocaine-dependent females, received placebo day 1, yohimbine day 2	Cocaine Males, Yohimbine Then Placebo n=12 Participants Cocaine-dependent males, received yohimbine day 1, placebo day 2	Cocaine Males, Placebo Then Yohimbine n=17 Participants Cocaine-dependent males, received placebo day 1, yohimbine day 2	Control Females, Yohimbine Then Placebo n=13 Participants non-dependent females, received yohimbine day and placebo day 2	Control Females, Placebo Then Yohimbine n=12 Participants non-dependent females, received placebo day and yohimbine day 2	Control Males, Yohimbine Then Placebo n=14 Participants non-dependent males, received yohimbine day and placebo day 2	Control Males, Placebo Then Yohimbine n=16 Participants non-dependent males, received placebo day and yohimbine day 2	Total n=112 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	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	17 Participants n=4 Participants	13 Participants n=21 Participants	12 Participants n=8 Participants	14 Participants n=8 Participants	16 Participants n=24 Participants	112 Participants n=42 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	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Continuous	43.1 years STANDARD_DEVIATION 10.1 • n=5 Participants	37.8 years STANDARD_DEVIATION 11.2 • n=7 Participants	39.8 years STANDARD_DEVIATION 10.9 • n=5 Participants	38.7 years STANDARD_DEVIATION 10.1 • n=4 Participants	36.2 years STANDARD_DEVIATION 13.2 • n=21 Participants	32.1 years STANDARD_DEVIATION 13.2 • n=8 Participants	32.7 years STANDARD_DEVIATION 13.3 • n=8 Participants	32.3 years STANDARD_DEVIATION 12.6 • n=24 Participants	36.8 years STANDARD_DEVIATION 12.1 • n=42 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	9 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	13 Participants n=21 Participants	12 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	53 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	12 Participants n=5 Participants	17 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	14 Participants n=8 Participants	16 Participants n=24 Participants	59 Participants n=42 Participants
Region of Enrollment United States	19 participants n=5 Participants	9 participants n=7 Participants	12 participants n=5 Participants	17 participants n=4 Participants	13 participants n=21 Participants	12 participants n=8 Participants	14 participants n=8 Participants	16 participants n=24 Participants	112 participants n=42 Participants

PRIMARY outcome

Timeframe: Post cocaine cue exposure

Outcome measures

Outcome measures
Measure	Cocaine Females Yohimbine n=28 Participants Cocaine-dependent females pre-treated with yohimbine	Cocaine Females Placebo n=28 Participants Cocaine-dependent females pre-treated with placebo	Cocaine Males Yohimbine n=30 Participants Cocaine-dependent males pre-treated with yohimbine	Cocaine Males Placebo n=30 Participants Cocaine-dependent males pre-treated with placebo	Control Females Yohimbine n=25 Participants	Control Females Placebo n=25 Participants	Control Males Yohimbine n=30 Participants	Control Males Placebo n=30 Participants
Cocaine Craving	4.8 units on a scale Standard Deviation 3.6	3.4 units on a scale Standard Deviation 3.6	3.0 units on a scale Standard Deviation 2.9	2.7 units on a scale Standard Deviation 3.1	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0

Adverse Events

Cocaine Females

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cocaine Males

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Females

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Males

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

Dr. McRae-Clark

Medical University of South Carolina

Phone: 843-792-5216

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place