Trial Outcomes & Findings for Treatment of Cocaine Dependence With Lisdexamfetamine (NCT NCT00958282)

Last Updated: 2015-09-17

Results Overview

At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

14 Weeks

Results posted on

2015-09-17

Participant Flow

Participant milestones

Participant milestones
Measure	Lisdexamfetamine lisdexamfetamine 70mg/day lisdexamfetamine cognitive behavioral therapy	Placebo Placebo Comparator once per day placebo cognitive behavioral therapy
Overall Study STARTED	22	21
Overall Study COMPLETED	12	15
Overall Study NOT COMPLETED	10	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Cocaine Dependence With Lisdexamfetamine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lisdexamfetamine n=22 Participants lisdexamfetamine 70mg/day lisdexamfetamine cognitive behavioral therapy	Placebo n=21 Participants Placebo Comparator once per day placebo cognitive behavioral therapy	Total n=43 Participants Total of all reporting groups
Age, Continuous	45.1 years STANDARD_DEVIATION 5.9 • n=39 Participants	46.4 years STANDARD_DEVIATION 10 • n=41 Participants	46.1 years STANDARD_DEVIATION 7.9 • n=35 Participants
Sex: Female, Male Female	4 Participants n=39 Participants	4 Participants n=41 Participants	8 Participants n=35 Participants
Sex: Female, Male Male	18 Participants n=39 Participants	17 Participants n=41 Participants	35 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	2 Participants n=41 Participants	2 Participants n=35 Participants
Race (NIH/OMB) Black or African American	14 Participants n=39 Participants	12 Participants n=41 Participants	26 Participants n=35 Participants
Race (NIH/OMB) White	8 Participants n=39 Participants	4 Participants n=41 Participants	12 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	3 Participants n=41 Participants	3 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment United States	22 participants n=39 Participants	21 participants n=41 Participants	43 participants n=35 Participants

PRIMARY outcome

Timeframe: 14 Weeks

Outcome measures

Outcome measures
Measure	Lisdexamfetamine n=22 Participants lisdexamfetamine 70mg/day lisdexamfetamine cognitive behavioral therapy	Placebo n=21 Participants Placebo Comparator once per day placebo cognitive behavioral therapy
Cocaine-positive Urine Results	86.5 percentage of BE urine tests Standard Deviation .5	92.4 percentage of BE urine tests Standard Deviation .5

SECONDARY outcome

Timeframe: 14 Weeks

On a weekly basis, patients completed measures of cocaine craving using the Minnesota Cocaine Craving Scale. The Minnesota Cocaine Craving Scale is a self report questionnaire and ranges from 0 to 100, 0 being "very little" to 100 being "very much".

Outcome measures

Outcome measures
Measure	Lisdexamfetamine n=22 Participants lisdexamfetamine 70mg/day lisdexamfetamine cognitive behavioral therapy	Placebo n=21 Participants Placebo Comparator once per day placebo cognitive behavioral therapy
Drug Craving	17.5 units on a scale Standard Error 3.30	28.7 units on a scale Standard Error 3.21

Adverse Events

Lisdexamfetamine/Behavior Therapy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lisdexamfetamine/Behavior Therapy n=22 participants at risk lisdexamfetamine 70mg/day plus Behavior Therapy lisdexamfetamine/Behavior Therapy	Placebo n=21 participants at risk Placebo Comparator once per day placebo
Cardiac disorders Angina	4.5% 1/22 • Number of events 1	0.00% 0/21
Psychiatric disorders Psychosis	0.00% 0/22	4.8% 1/21 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marc Mooney

University of Minnesota

Phone: 6129916875

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place