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Trial Outcomes & Findings for Carbidopa/Levodopa Combined With Behavioral Therapy for the Treatment of Cocaine Dependence (NCT NCT00713583)

NCT ID: NCT00713583

Last Updated: 2018-04-23

Results Overview

The Treatment Effectiveness Score (TES) is the number of cocaine-negative urines collected out of the total scheduled urine tests for the 12-week trial (36 total scheduled urine tests per participant). The mean number of cocaine-negative urines over all time points is reported in this outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

85 participants

Primary outcome timeframe

12 weeks of treatment

Results posted on

2018-04-23

Participant Flow

Participant milestones

Participant milestones
Measure
Levodopa Pharmacotherapy
Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM).
Placebo
Placebo, cognitive behavioral therapy (CBT), and contingency management (CM).
Overall Study
STARTED
45
40
Overall Study
COMPLETED
45
40
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carbidopa/Levodopa Combined With Behavioral Therapy for the Treatment of Cocaine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Levodopa Pharmacotherapy
n=45 Participants
Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM).
Placebo
n=40 Participants
Placebo, cognitive behavioral therapy (CBT), and contingency management (CM).
Total
n=85 Participants
Total of all reporting groups
Age, Continuous
46 years
STANDARD_DEVIATION 7.9 • n=93 Participants
45 years
STANDARD_DEVIATION 9.2 • n=4 Participants
46 years
STANDARD_DEVIATION 8.5 • n=27 Participants
Sex: Female, Male
Female
10 Participants
n=93 Participants
5 Participants
n=4 Participants
15 Participants
n=27 Participants
Sex: Female, Male
Male
35 Participants
n=93 Participants
35 Participants
n=4 Participants
70 Participants
n=27 Participants
Region of Enrollment
United States
45 Participants
n=93 Participants
40 Participants
n=4 Participants
85 Participants
n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks of treatment

The Treatment Effectiveness Score (TES) is the number of cocaine-negative urines collected out of the total scheduled urine tests for the 12-week trial (36 total scheduled urine tests per participant). The mean number of cocaine-negative urines over all time points is reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Levodopa Pharmacotherapy
n=45 Participants
Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM).
Placebo
n=40 Participants
Placebo, cognitive behavioral therapy (CBT), and contingency management (CM).
Confirmed Abstinence From Cocaine as Assessed by Treatment Effectiveness Score (TES)
7 cocaine-negative urines
Standard Deviation 11.7
9 cocaine-negative urines
Standard Deviation 12.6

Adverse Events

Levodopa Pharmacotherapy

Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Levodopa Pharmacotherapy
n=45 participants at risk
Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM).
Placebo
n=40 participants at risk
Placebo, cognitive behavioral therapy (CBT), and contingency management (CM).
Gastrointestinal disorders
Stomach pain
2.2%
1/45 • Number of events 1 • 12 weeks
0.00%
0/40 • 12 weeks
Psychiatric disorders
Depression
2.2%
1/45 • Number of events 1 • 12 weeks
0.00%
0/40 • 12 weeks
Eye disorders
Photosensitivity
2.2%
1/45 • Number of events 1 • 12 weeks
0.00%
0/40 • 12 weeks
General disorders
Head injury
2.2%
1/45 • Number of events 1 • 12 weeks
0.00%
0/40 • 12 weeks
Psychiatric disorders
Suicide ideation
0.00%
0/45 • 12 weeks
2.5%
1/40 • Number of events 1 • 12 weeks
Infections and infestations
abscess
0.00%
0/45 • 12 weeks
2.5%
1/40 • Number of events 1 • 12 weeks
General disorders
Transient inability to speak
2.2%
1/45 • Number of events 1 • 12 weeks
0.00%
0/40 • 12 weeks
Vascular disorders
Pulmonary embolism
0.00%
0/45 • 12 weeks
2.5%
1/40 • Number of events 1 • 12 weeks
Vascular disorders
Blood clot
2.2%
1/45 • Number of events 1 • 12 weeks
0.00%
0/40 • 12 weeks

Other adverse events

Adverse event data not reported

Additional Information

Joy M. Schmitz, PhD

The University of Texas Health Science Center at Houston

Phone: (713) 486-2867

Results disclosure agreements

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