A Sequenced Behavioral and Medication Intervention for Cocaine Dependence

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2021-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders

NCT03344419

Cocaine Use Disorder

SUSPENDED PHASE3

Cognitive Enhancement and Relapse Prevention in Cocaine Addiction

NCT01067846

Cocaine Addiction

COMPLETED NA

Developing Computer Based Treatments for Addiction

NCT00586534

Cocaine Addiction

COMPLETED NA

Extending Long-term Outcomes Through an Adaptive Aftercare Intervention

NCT02143063

Cocaine Use Disorder Contingency Management

COMPLETED NA

Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction

NCT01978457

Cocaine Dependent Subjects

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cocaine Dependence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Computer-assisted CBT plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)

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.

Group Type EXPERIMENTAL

Computer-assisted behavior therapy

Intervention Type BEHAVIORAL

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.

Mixed-Amphetamine Salts- Extended Release (MAS-ER)

Intervention Type DRUG

80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT

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. 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.

Group Type PLACEBO_COMPARATOR

Computer-assisted behavior therapy

Intervention Type BEHAVIORAL

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.

Placebo

Intervention Type DRUG

Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Mixed-Amphetamine Salts- Extended Release (MAS-ER)

80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT

Intervention Type DRUG

Placebo

Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Therapeutic Educational System (TES) Adderall XR Computer-assisted CBT, TES

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No