Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 92 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

Improving Learning-based Treatment of Cocaine Dependence With Medication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01526538
Recruitment Status : Completed
First Posted : February 6, 2012
Results First Posted : February 15, 2017
Last Update Posted : February 15, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Matthew Johnson, Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition COCAINE-RELATED DISORDERS
Interventions Drug: d-cycloserine
Drug: sugar pill
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 50 mg D-cycloserine Sugar Pill
Hide Arm/Group Description

active drug condition

d-cycloserine: 50 mg d-cycloserine

Inactive placebo

sugar pill: placebo

Period Title: Overall Study
Started 30 22
Completed 21 18
Not Completed 9 4
Arm/Group Title 50 mg D-cycloserine Sugar Pill Total
Hide Arm/Group Description

active drug condition

d-cycloserine: 50 mg d-cycloserine

Inactive placebo

sugar pill: placebo

Total of all reporting groups
Overall Number of Baseline Participants 21 18 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 18 participants 39 participants
51.3  (5.3) 52.1  (4.9) 51.7  (5.1)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 18 participants 39 participants
Female
6
  28.6%
6
  33.3%
12
  30.8%
Male
15
  71.4%
12
  66.7%
27
  69.2%
1.Primary Outcome
Title Urinalysis Benzoylecgonine (Cocaine Metabolite)(ng/ml)
Hide Description The primary outcome for this study will be post-treatment continuous abstinence, as assessed by urinalysis results
Time Frame 1 month post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50 mg D-cycloserine Sugar Pill
Hide Arm/Group Description:

active drug condition

d-cycloserine: 50 mg d-cycloserine

Inactive placebo

sugar pill: placebo

Overall Number of Participants Analyzed 22 18
Mean (Standard Deviation)
Unit of Measure: ng/ml
36.7  (7.7) 32.4  (6.6)
2.Primary Outcome
Title Medication Side-effects
Hide Description self-report of medication side effects (Units of Measure is the count of specific reported effects)
Time Frame 1 month post-treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine Control
Hide Arm/Group Description:
Study medication under investigation
Placebo (sugar pill)
Overall Number of Participants Analyzed 21 18
Measure Type: Number
Unit of Measure: Adverse event reports
0 0
3.Secondary Outcome
Title Learning Task by Itami and Uno
Hide Description [Not Specified]
Time Frame At the baseline laboratory visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50 mg D-cycloserine Sugar Pill
Hide Arm/Group Description:

active drug condition

d-cycloserine: 50 mg d-cycloserine

Inactive placebo

sugar pill: placebo

Overall Number of Participants Analyzed 21 18
Mean (Standard Error)
Unit of Measure: % correct
81.5  (3.5) 72.9  (4.4)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 50 mg D-cycloserine Sugar Pill
Hide Arm/Group Description

active drug condition

d-cycloserine: 50 mg d-cycloserine

Inactive placebo

sugar pill: placebo

All-Cause Mortality
50 mg D-cycloserine Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
50 mg D-cycloserine Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
50 mg D-cycloserine Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/18 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Matthew Johnson Ph.D.
Organization: Johns Hopkins University
Phone: 4105500056
EMail: mwj@jhu.edu
Responsible Party: Matthew Johnson, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01526538     History of Changes
Other Study ID Numbers: R21DA029823 ( U.S. NIH Grant/Contract )
First Submitted: January 30, 2012
First Posted: February 6, 2012
Results First Submitted: September 10, 2015
Results First Posted: February 15, 2017
Last Update Posted: February 15, 2017