Trial Outcomes & Findings for Improving Learning-based Treatment of Cocaine Dependence With Medication (NCT NCT01526538)

NCT ID: NCT01526538

Last Updated: 2017-02-15

Results Overview

The primary outcome for this study will be post-treatment continuous abstinence, as assessed by urinalysis results

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: 1 month post-treatment
• Results posted on: 2017-02-15

Participant Flow

Participant milestones

Measure	50 mg D-cycloserine active drug condition d-cycloserine: 50 mg d-cycloserine	Sugar Pill Inactive placebo sugar pill: placebo
Overall Study STARTED	30	22
Overall Study COMPLETED	21	18
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Learning-based Treatment of Cocaine Dependence With Medication

Baseline characteristics by cohort

Measure	50 mg D-cycloserine n=21 Participants active drug condition d-cycloserine: 50 mg d-cycloserine	Sugar Pill n=18 Participants Inactive placebo sugar pill: placebo	Total n=39 Participants Total of all reporting groups
Age, Continuous	51.3 years STANDARD_DEVIATION 5.3 • n=5 Participants	52.1 years STANDARD_DEVIATION 4.9 • n=7 Participants	51.7 years STANDARD_DEVIATION 5.1 • n=5 Participants
Gender Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Gender Male	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month post-treatment

The primary outcome for this study will be post-treatment continuous abstinence, as assessed by urinalysis results

Outcome measures

Measure	50 mg D-cycloserine n=22 Participants active drug condition d-cycloserine: 50 mg d-cycloserine	Sugar Pill n=18 Participants Inactive placebo sugar pill: placebo
Urinalysis Benzoylecgonine (Cocaine Metabolite)(ng/ml)	36.7 ng/ml Standard Deviation 7.7	32.4 ng/ml Standard Deviation 6.6

PRIMARY outcome

Timeframe: 1 month post-treatment.

self-report of medication side effects (Units of Measure is the count of specific reported effects)

Outcome measures

Measure	50 mg D-cycloserine n=21 Participants active drug condition d-cycloserine: 50 mg d-cycloserine	Sugar Pill n=18 Participants Inactive placebo sugar pill: placebo
Medication Side-effects	0 Adverse event reports	0 Adverse event reports

SECONDARY outcome

Timeframe: At the baseline laboratory visit

Outcome measures

Measure	50 mg D-cycloserine n=21 Participants active drug condition d-cycloserine: 50 mg d-cycloserine	Sugar Pill n=18 Participants Inactive placebo sugar pill: placebo
Learning Task by Itami and Uno	81.5 % correct Standard Error 3.5	72.9 % correct Standard Error 4.4

Adverse Events

50 mg D-cycloserine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

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

Matthew Johnson Ph.D.

Johns Hopkins University

Phone: 4105500056

Email: mwj@jhu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place