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A Sequenced Behavioral and Medication Intervention for Cocaine Dependence

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: NCT01986075
Recruitment Status : Active, not recruiting
First Posted : November 18, 2013
Last Update Posted : September 11, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Frances R Levin, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Behavioral: Computer-assisted behavior therapy Drug: Mixed amphetamine salts Drug: Computer-assisted CBT plus placebo Phase 1 Phase 2

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 155 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Sequenced Behavioral and Medication Intervention for Cocaine Dependence
Actual Study Start Date : January 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Active Comparator: Computer-assisted Therapy alone
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 when receiving Behavioral: Computer assisted therapy alone.
Behavioral: Computer-assisted behavior therapy
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.
Other Name: Therapeutic Educational System (TES)

Experimental: Computer-assisted CBT + Adderall-XR
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.
Behavioral: Computer-assisted behavior therapy
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.
Other Name: Therapeutic Educational System (TES)

Drug: Mixed amphetamine salts
80 mg/day of Adderall-XR
Other Name: Adderall XR

Placebo Comparator: Computer-assisted CBT plus placebo
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.
Behavioral: Computer-assisted behavior therapy
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.
Other Name: Therapeutic Educational System (TES)

Drug: Computer-assisted CBT plus placebo
Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)
Other Name: Computer-assisted CBT, TES




Primary Outcome Measures :
  1. Three weeks of cocaine abstinence [ Time Frame: 14 weeks ]
    The primary outcome measure will be a binary indicator (yes or no) of at least 3 weeks of urine toxicology confirmed self-reported abstinence during assessed between weeks 5 and 14.


Secondary Outcome Measures :
  1. Proportion of cocaine positive urines [ Time Frame: 14 Weeks ]
    The proportion of weekly urine toxicology samples testing positive for benzoylecgonine over the course of the 14 week treatment trial.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meets DSM-V criteria for cocaine use disorder.
  2. Used cocaine at least four days in the past month.
  3. Age 18-60.
  4. Able to give informed consent and comply with study procedures

Exclusion Criteria:

  1. Meets DSM-V criteria for bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse.
  2. 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.
  3. History of seizures, unexplained loss of consciousness, or traumatic brain injury.
  4. History of allergic reaction to candidate medication (amphetamine).
  5. Significant current suicidal risk.
  6. Pregnancy, lactation, or failure in sexually active female patients to use adequate contraceptive methods.
  7. Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension, acute hepatitis, uncontrolled diabetes.
  8. Elevated transaminase levels (> 3x the normal limit).
  9. Coronary vascular disease
  10. History of failure to respond to a previous adequate trial of the candidate medication.
  11. Current physiological dependence on any other substance other than nicotine or cannabis that would require a medically supervised detoxification.
  12. Currently being prescribed psychotropic medication by another physician.
  13. Are legally mandated (e.g. to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program.
  14. Body Mass Index (BMI) < 18kg/m2. (amphetamine may produce weigh loss thus a minimum BMI cut-off is being used for study inclusion).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986075


Locations
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United States, New York
STARS
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Frances R Levin, M.D. Columbia University/New York State Psychiatric Institute
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Frances R Levin, Director of Substance Use Disorder, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01986075    
Other Study ID Numbers: #6850
R01DA034087-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Frances R Levin, New York State Psychiatric Institute:
Cocaine Dependence Treatment
Computer-assisted therapy
Pharmacotherapy
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Amphetamine
Adderall
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors