Trial Outcomes & Findings for Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence (NCT NCT00385268)

Last Updated: 2020-07-10

Results Overview

cocaine abstinent weeks determined by all negative urine drug screens in each week (2 urine drug screens per week)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

8 weeks

Results posted on

2020-07-10

Participant milestones
Measure	Acamprosate 1998mg/day for 8 weeks Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions. acamprosate : 1998 mg/dau fpr 8 weeks	Placebo placebo pills for 8 weeks Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions. placebo : placebo pills
Overall Study STARTED	34	26
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	16	8

Withdrawal data not reported

Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence

Baseline characteristics by cohort
Measure	Acamprosate n=34 Participants 1998mg/day for 8 weeks Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions. acamprosate : 1998 mg/dau fpr 8 weeks	Placebo n=26 Participants placebo pills for 8 weeks Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions. placebo : placebo pills	Total n=60 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
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	26 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.3 years STANDARD_DEVIATION 8.8 • n=5 Participants	46.1 years STANDARD_DEVIATION 7.7 • n=7 Participants	45.5 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	20 Participants n=7 Participants	45 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	26 participants n=7 Participants	60 participants n=5 Participants

Timeframe: 8 weeks

cocaine abstinent weeks determined by all negative urine drug screens in each week (2 urine drug screens per week)

Outcome measures
Measure	Acamprosate n=34 Participants 1998mg/day for 8 weeks Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions. acamprosate : 1998 mg/dau fpr 8 weeks	Placebo n=26 Participants placebo pills for 8 weeks Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions. placebo : placebo pills
Cocaine Use Over the Eight Week Trial as Measured by Twice Weekly Urine Drug Screen	1.3 cocaine abstinent weeks Standard Deviation 2.3	1.2 cocaine abstinent weeks Standard Deviation 2.3

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Acamprosate n=34 participants at risk 1998mg/day for 8 weeks Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions. acamprosate : 1998 mg/dau fpr 8 weeks	Placebo n=26 participants at risk placebo pills for 8 weeks Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions. placebo : placebo pills
General disorders Aches and Pains	38.2% 13/34	50.0% 13/26

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