Back to resultsCarbidopa/Levodopa Combined With Behavioral Therapy for the Treatment of Cocaine Dependence
Primary Purpose
Cocaine Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
levodopa
Placebo
Cognitive Behavioral Therapy
Contingency Management
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Dependence focused on measuring Cocaine, levodopa, contingency management
Eligibility Criteria
Inclusion Criteria:
- between 18 and 60 years of age
- meet Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) criteria for current cocaine dependence.
- be in acceptable health on the basis of interview, medical history and physical exam.
Exclusion Criteria:
- current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine.
- have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe.
- have significant current suicidal or homicidal ideation.
- have medical conditions contraindicating levodopa/carbidopa pharmacotherapy. Conditions include severe pulmonary disease (bronchial asthma, emphysema), cardiovascular disease (severe or history of myocardial infarction with residual arrhythmias), narrow angle glaucoma, melanoma, history of peptic ulcer, renal function impairment.
- taking medications known to have significant drug interactions with levodopa/carbidopa (e.g., monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, selegiline, anesthetics).
- currently or recently (last 3 months) treated for substance use or another psychiatric condition.
- having conditions of probation or parole requiring reports of drug use to officers of the court.
- impending incarceration.
- pregnant or nursing for female patients.
- inability to read, write, or speak English.
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Levodopa pharmacotherapy
Placebo
Arm Description
Levodopa pharmacotherapy (800mg levodopa and 200mg carbidopa per day), cognitive behavioral therapy (CBT), and contingency management (CM).
Placebo, cognitive behavioral therapy (CBT), and contingency management (CM).
Outcomes
Primary Outcome Measures
Confirmed Abstinence From Cocaine as Assessed by Treatment Effectiveness Score (TES)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00713583
First Posted
July 9, 2008
Last Updated
March 23, 2018
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00713583
Brief Title
Carbidopa/Levodopa Combined With Behavioral Therapy for the Treatment of Cocaine Dependence
Official Title
Contingency Management Plus Levodopa/Carbidopa for Treatment of Cocaine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cocaine dependence is a major public health problem and the development of a treatment for this disorder is a priority. To date, treatment interventions based on positive incentive principles have shown the strongest effects for improving substance use outcomes. One such example is contingency management (CM) interventions in which nondrug rewards are used to compete with cocaine. Recent evidence suggests that certain medications improve response to CM interventions, particularly agents that target dopamine reward systems in the brain. A promising dopamine-enhancing medication is levodopa. The study team has observed the strongest effects of levodopa when the medication is administered in the context of CM therapy, perhaps through mechanisms that enhance reward saliency. The proposed study is designed to further evaluate this promising treatment approach. Cocaine dependent outpatients will participate in a randomized, 2-group (levodopa vs. placebo), double-blind clinical trial. CM will be behavioral therapy platform for both treatment groups. The study will test the primary hypothesis that CM+levodopa will be more effective than CM+placebo in reducing cocaine use. This study is expected to validate the usefulness of a new behavioral-pharmacological treatment approach for cocaine dependence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
Cocaine, levodopa, contingency management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levodopa pharmacotherapy
Arm Type
Experimental
Arm Description
Levodopa pharmacotherapy (800mg levodopa and 200mg carbidopa per day), cognitive behavioral therapy (CBT), and contingency management (CM).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, cognitive behavioral therapy (CBT), and contingency management (CM).
Intervention Type
Drug
Intervention Name(s)
levodopa
Other Intervention Name(s)
Sinemet
Intervention Description
800mg levodopa and 200mg carbidopa per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Participants received individual cognitive behavioral therapy (CBT) in 50-minute weekly sessions. These sessions were manual-driven and based on the relapse prevention model proposed by Marlatt and Gordon (1985). Trained masters-level therapists, under the supervision of senior therapists and the principal investigator, worked with participants to teach them how to recognize and cope with risky situations that could influence their cocaine use through self-monitoring of situational craving and drug use stimuli, coping skills training, and lifestyle modifications.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
An abstinence-based contingency management (CM) procedure was used. Participants earned vouchers according to the reward schedule recommended by Budney and Higgins (1998), beginning at $2.50 for the first cocaine-negative urine. For each consecutive cocaine-negative urine, voucher values increased by $1.25 with a $10 bonus given for provision of three consecutive cocaine-negative urines within a week. A cocaine-positive urine or failure to provide a scheduled urine sample resulted in a reset of the schedule to the initial value of $2.50. After provision of five negative urines, the voucher returned to the value prior to the reset. Participants were able to redeem their vouchers for small amounts of cash (≤$25) or gift cards for goods and services.
Primary Outcome Measure Information:
Title
Confirmed Abstinence From Cocaine as Assessed by Treatment Effectiveness Score (TES)
Description
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.
Time Frame
12 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
between 18 and 60 years of age
meet Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) criteria for current cocaine dependence.
be in acceptable health on the basis of interview, medical history and physical exam.
Exclusion Criteria:
current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine.
have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe.
have significant current suicidal or homicidal ideation.
have medical conditions contraindicating levodopa/carbidopa pharmacotherapy. Conditions include severe pulmonary disease (bronchial asthma, emphysema), cardiovascular disease (severe or history of myocardial infarction with residual arrhythmias), narrow angle glaucoma, melanoma, history of peptic ulcer, renal function impairment.
taking medications known to have significant drug interactions with levodopa/carbidopa (e.g., monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, selegiline, anesthetics).
currently or recently (last 3 months) treated for substance use or another psychiatric condition.
having conditions of probation or parole requiring reports of drug use to officers of the court.
impending incarceration.
pregnant or nursing for female patients.
inability to read, write, or speak English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy M Schmitz, PhD
Organizational Affiliation
University of Texas at Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Carbidopa/Levodopa Combined With Behavioral Therapy for the Treatment of Cocaine Dependence
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