Back to resultsA Sequenced Behavioral and Medication Intervention for Cocaine Dependence
Primary Purpose
Cocaine Dependence
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computer-assisted behavior therapy
Mixed-Amphetamine Salts- Extended Release (MAS-ER)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Dependence focused on measuring Cocaine Dependence Treatment, Computer-assisted therapy, Pharmacotherapy
Eligibility Criteria
Inclusion Criteria:
- Meets DSM-V criteria for cocaine use disorder.
- Used cocaine at least four days in the past month.
- Age 18-60.
- Able to give informed consent and comply with study procedures
Exclusion Criteria:
- Meets DSM-V criteria for bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse.
- Participants with MDD, with symptom severity that exceeds a HAM-D score of 20, and/or any other current Axis I psychiatric disorder as defined by DSM-V supported by the MINI that in the investigator's judgment are unstable, would be disrupted by study medication, or are likely to require specialized pharmacotherapy or psychotherapy during the study period.
- History of seizures, unexplained loss of consciousness, or traumatic brain injury.
- History of allergic reaction to candidate medication (amphetamine).
- Significant current suicidal risk.
- Pregnancy, lactation, or failure in sexually active female patients to use adequate contraceptive methods.
- Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension, acute hepatitis, uncontrolled diabetes.
- Elevated transaminase levels (> 3x the normal limit).
- Coronary vascular disease
- History of failure to respond to a previous adequate trial of the candidate medication.
- Current physiological dependence on any other substance other than nicotine or cannabis that would require a medically supervised detoxification.
- Currently being prescribed psychotropic medication by another physician.
- Are legally mandated (e.g. to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program.
- Body Mass Index (BMI) < 18kg/m2. (amphetamine may produce weigh loss thus a minimum BMI cut-off is being used for study inclusion).
Sites / Locations
- STARS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Computer-assisted CBT plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)
Computer-assisted CBT plus placebo
Arm Description
Patients who are randomized to the computer-assisted behavior therapy plus mixed amphetamine salts (extended release) arm will have their dose titrated to 80 mg or the maximum tolerated extended release mixed amphetamine salts daily. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.
Patients who are randomized to the Computer-assisted CBT plus placebo arm will have their medication dose titrated in a fix-flexible dose schedule matching the active medication arm. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.
Outcomes
Primary Outcome Measures
Those Achieving Three Consecutive Weeks of Cocaine Abstinence at the End of the Trial.
The primary outcome measure will be a binary indicator (yes or no) of at least 3 consecutive weeks of urine toxicology confirmed self-reported abstinence during the last three weeks of the trial.
Secondary Outcome Measures
Full Information
NCT ID
NCT01986075
First Posted
November 11, 2013
Last Updated
January 24, 2022
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01986075
Brief Title
A Sequenced Behavioral and Medication Intervention for Cocaine Dependence
Official Title
A Sequenced Behavioral and Medication Intervention for Cocaine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
January 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will investigate a treatment strategy in which a computer-assisted behavioral intervention will be used to help individuals stop their use of cocaine. A medication will be combined with the behavioral treatment among those individuals who do not respond to the behavioral intervention alone. The primary hypothesis of the study is that among cocaine dependent individuals who fail to respond to an initial trial of behavioral therapy, a greater proportion of individuals will benefit from the combined treatment (behavior therapy plus medication) compared to individuals in the comparison group.
Detailed Description
Cocaine Dependence is associated with substantial social, physical, and neurobiological problems. Psychosocial treatments can be helpful for many individuals. However, a significant proportion of individuals do not benefit from counseling alone. Our research group has demonstrated that deficient dopamine transmission, predicts poor response to a behavioral treatment and that a regiment that included an agonist replacement strategy with stimulants maybe effective for promoting abstinence in severe cocaine dependent patients.
In this 15-week study 145 treatment-seeking cocaine dependent participants will receive a computer-assisted behavioral intervention based on the community reinforcement approach with contingency management (CRA + CM). The counseling approach will include both computer-assisted life skills training via and counseling. Individuals who fail to achieve abstinence will continue the behavioral treatment (CRA + CM) and will be randomly assigned to a behavioral therapy enhancement strategy that will include either Mixed Amphetamine Salts-Extended Release (80mg) or placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
Cocaine Dependence Treatment, Computer-assisted therapy, Pharmacotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Following an initial 4 week period where participants received computer-assisted behavioral intervention based on the community reinforcement approach with contingency management (CRA + CM), individuals who failed to achieve abstinence will continue the behavioral treatment (CRA + CM) and will be randomly assigned, in parallel, to a behavioral therapy enhancement strategy that will include either Mixed Amphetamine Salts-Extended Release (80mg) or placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computer-assisted CBT plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)
Arm Type
Experimental
Arm Description
Patients who are randomized to the computer-assisted behavior therapy plus mixed amphetamine salts (extended release) arm will have their dose titrated to 80 mg or the maximum tolerated extended release mixed amphetamine salts daily. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.
Arm Title
Computer-assisted CBT plus placebo
Arm Type
Placebo Comparator
Arm Description
Patients who are randomized to the Computer-assisted CBT plus placebo arm will have their medication dose titrated in a fix-flexible dose schedule matching the active medication arm. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.
Intervention Type
Behavioral
Intervention Name(s)
Computer-assisted behavior therapy
Other Intervention Name(s)
Therapeutic Educational System (TES)
Intervention Description
TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.
Intervention Type
Drug
Intervention Name(s)
Mixed-Amphetamine Salts- Extended Release (MAS-ER)
Other Intervention Name(s)
Adderall XR
Intervention Description
80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Computer-assisted CBT, TES
Intervention Description
Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)
Primary Outcome Measure Information:
Title
Those Achieving Three Consecutive Weeks of Cocaine Abstinence at the End of the Trial.
Description
The primary outcome measure will be a binary indicator (yes or no) of at least 3 consecutive weeks of urine toxicology confirmed self-reported abstinence during the last three weeks of the trial.
Time Frame
weeks 12-14 of trial
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:
Meets DSM-V criteria for cocaine use disorder.
Used cocaine at least four days in the past month.
Age 18-60.
Able to give informed consent and comply with study procedures
Exclusion Criteria:
Meets DSM-V criteria for bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse.
Participants with MDD, with symptom severity that exceeds a HAM-D score of 20, and/or any other current Axis I psychiatric disorder as defined by DSM-V supported by the MINI that in the investigator's judgment are unstable, would be disrupted by study medication, or are likely to require specialized pharmacotherapy or psychotherapy during the study period.
History of seizures, unexplained loss of consciousness, or traumatic brain injury.
History of allergic reaction to candidate medication (amphetamine).
Significant current suicidal risk.
Pregnancy, lactation, or failure in sexually active female patients to use adequate contraceptive methods.
Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension, acute hepatitis, uncontrolled diabetes.
Elevated transaminase levels (> 3x the normal limit).
Coronary vascular disease
History of failure to respond to a previous adequate trial of the candidate medication.
Current physiological dependence on any other substance other than nicotine or cannabis that would require a medically supervised detoxification.
Currently being prescribed psychotropic medication by another physician.
Are legally mandated (e.g. to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program.
Body Mass Index (BMI) < 18kg/m2. (amphetamine may produce weigh loss thus a minimum BMI cut-off is being used for study inclusion).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances R Levin, M.D.
Organizational Affiliation
Columbia University/New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
STARS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18489017
Citation
Bickel WK, Marsch LA, Buchhalter AR, Badger GJ. Computerized behavior therapy for opioid-dependent outpatients: a randomized controlled trial. Exp Clin Psychopharmacol. 2008 Apr;16(2):132-43. doi: 10.1037/1064-1297.16.2.132.
Results Reference
background
PubMed Identifier
33086160
Citation
Blevins D, Carpenter KM, Martinez D, Mariani JJ, Levin FR. An adaptive clinical trial design for cocaine use disorder: Extended-release amphetamine salts for early behavioral intervention non-responders. Contemp Clin Trials. 2020 Nov;98:106187. doi: 10.1016/j.cct.2020.106187. Epub 2020 Oct 18.
Results Reference
derived
Links:
URL
http://stars.columbia.edu
Description
Click here for more information about the study and clinic
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A Sequenced Behavioral and Medication Intervention for Cocaine Dependence
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