A Sequenced Behavioral and Medication Intervention for Cocaine Dependence

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01986075
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
145
1
2
84
1.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Computer-assisted behavior therapy
  • Drug: Mixed-Amphetamine Salts- Extended Release (MAS-ER)
  • Drug: 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 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
145 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention 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.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:
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 :
Jan 1, 2014
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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 Names:
  • Therapeutic Educational System (TES)
  • Drug: Mixed-Amphetamine Salts- Extended Release (MAS-ER)
    80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT
    Other Names:
  • 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. 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.

    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 Names:
  • Therapeutic Educational System (TES)
  • Drug: Placebo
    Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)
    Other Names:
  • Computer-assisted CBT, TES
  • Outcome Measures

    Primary Outcome Measures

    1. Those Achieving Three Consecutive Weeks of Cocaine Abstinence at the End of the Trial. [weeks 12-14 of 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.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 STARS New York New York United States 10032

    Sponsors and Collaborators

    • New York State Psychiatric Institute
    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Principal Investigator: Frances R Levin, M.D., Columbia University/New York State Psychiatric Institute

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    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
    First Posted:
    Nov 18, 2013
    Last Update Posted:
    Jan 25, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Frances R Levin, Director of Substance Use Disorder, New York State Psychiatric Institute
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Of the 145 participants enrolled, 21 participants were designated as treatment responders during the first month of the psychosocial intervention and were not randomized. An additional 38 individuals were lost to follow-up or not eligible to be randomized prior to completing the first month of the intervention. Eighty-six participants continued to use cocaine through the first month of treatment and were randomized to receive either MAS-XR or Placebo at the beginning of treatment week 5.
    Arm/Group Title Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER) Computer-assisted CBT Plus Placebo Computer- Assisted CBT With Contingency Management
    Arm/Group 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. 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. Mixed amphetamine salts: 80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT 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. 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. Placebo: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR) All participants received computer-assisted CBT with contingency management (CRA + CM) during the first 4 week period of the trial.
    Period Title: Initial CBT + CM (Pre-randomization)
    STARTED 0 0 145
    COMPLETED 0 0 86
    NOT COMPLETED 0 0 59
    Period Title: Initial CBT + CM (Pre-randomization)
    STARTED 45 41 0
    COMPLETED 30 27 0
    NOT COMPLETED 15 14 0

    Baseline Characteristics

    Arm/Group Title Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER) Computer-assisted CBT Plus Placebo Non-randomized Individuals Total
    Arm/Group 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. 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. Mixed amphetamine salts: 80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT 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. 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. Placebo: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR) Patients who were enrolled in the initial 4 week period and received CBT + CM but were not eligible to be randomized and did not enter the second randomized period of the trial. Total of all reporting groups
    Overall Participants 45 41 59 145
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    44.7
    (10.1)
    44.6
    (9.8)
    42.9
    (10.1)
    44.0
    (10.0)
    Sex: Female, Male (Count of Participants)
    Female
    7
    15.6%
    8
    19.5%
    8
    13.6%
    23
    15.9%
    Male
    38
    84.4%
    33
    80.5%
    51
    86.4%
    122
    84.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    11
    24.4%
    9
    22%
    15
    25.4%
    35
    24.1%
    Not Hispanic or Latino
    34
    75.6%
    32
    78%
    44
    74.6%
    110
    75.9%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    1
    2.2%
    3
    7.3%
    1
    1.7%
    5
    3.4%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    20
    44.4%
    17
    41.5%
    23
    39%
    60
    41.4%
    White
    19
    42.2%
    20
    48.8%
    22
    37.3%
    61
    42.1%
    More than one race
    3
    6.7%
    1
    2.4%
    9
    15.3%
    13
    9%
    Unknown or Not Reported
    2
    4.4%
    0
    0%
    4
    6.8%
    6
    4.1%
    Region of Enrollment (participants) [Number]
    United States
    45
    100%
    41
    100%
    59
    100%
    145
    100%
    Number of days of cocaine use during prior 28 days (days) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [days]
    11.4
    (6.1)
    13.9
    (7.2)
    12.2
    (7.4)
    12.6
    (6.7)

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER) Computer-assisted CBT Plus Placebo
    Arm/Group 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. 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. Mixed amphetamine salts: 80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT 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. 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. Placebo: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)
    Measure Participants 45 41
    Count of Participants [Participants]
    7
    15.6%
    5
    12.2%

    Adverse Events

    Time Frame During 15 weeks of trial, or length of individual's participation
    Adverse Event Reporting Description Adverse events are reported for those individuals randomized to either of the two arms MAS-ER or placebo as well as those non-randomized individuals who received CBT plus CM
    Arm/Group Title Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER) Computer-assisted CBT Plus Placebo Non-randomized CBT Plus CM
    Arm/Group 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. 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. Mixed amphetamine salts: 80 mg/day of Adderall-XR and computer -assisted CBT 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. 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. Placebo: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR) Fifty nine individuals who were not randomized and only exposed to CBT and CM. 21 participants were designated as treatment responders during the first month of the psychosocial intervention and were not randomized. An additional 38 individuals were lost to follow-up or not eligible to be randomized prior to completing the first month of the intervention.
    All Cause Mortality
    Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER) Computer-assisted CBT Plus Placebo Non-randomized CBT Plus CM
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/45 (0%) 0/41 (0%) 0/59 (0%)
    Serious Adverse Events
    Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER) Computer-assisted CBT Plus Placebo Non-randomized CBT Plus CM
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/45 (2.2%) 1/41 (2.4%) 4/59 (6.8%)
    Cardiac disorders
    atrial fibrillation 0/45 (0%) 0 0/41 (0%) 0 1/59 (1.7%) 1
    Gastrointestinal disorders
    GI issue 0/45 (0%) 0 0/41 (0%) 0 1/59 (1.7%) 1
    General disorders
    inpatient rehabilitation stay 0/45 (0%) 0 1/41 (2.4%) 1 1/59 (1.7%) 1
    dehydration 1/45 (2.2%) 1 0/41 (0%) 0 0/59 (0%) 0
    hernia 0/45 (0%) 0 0/41 (0%) 0 1/59 (1.7%) 1
    Other (Not Including Serious) Adverse Events
    Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER) Computer-assisted CBT Plus Placebo Non-randomized CBT Plus CM
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 26/45 (57.8%) 11/41 (26.8%) 2/59 (3.4%)
    Cardiac disorders
    hypertension 6/45 (13.3%) 6 2/41 (4.9%) 2 0/59 (0%) 0
    Gastrointestinal disorders
    nausea 9/45 (20%) 9 2/41 (4.9%) 2 0/59 (0%) 0
    constipation 3/45 (6.7%) 3 2/41 (4.9%) 2 0/59 (0%) 0
    General disorders
    insomnia 14/45 (31.1%) 14 2/41 (4.9%) 2 0/59 (0%) 0
    irritability 5/45 (11.1%) 5 3/41 (7.3%) 3 0/59 (0%) 0
    headache 3/45 (6.7%) 3 3/41 (7.3%) 3 1/59 (1.7%) 1
    appetite loss 4/45 (8.9%) 4 1/41 (2.4%) 1 0/59 (0%) 0
    dry mouth 4/45 (8.9%) 4 1/41 (2.4%) 1 0/59 (0%) 0
    Psychiatric disorders
    anxiety 10/45 (22.2%) 10 3/41 (7.3%) 3 1/59 (1.7%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Kenneth Carpenter, PhD
    Organization New York State Psychiatric Institute
    Phone 646-774-8181
    Email kenneth.carpenter@nyspi.columbia.edu
    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
    First Posted:
    Nov 18, 2013
    Last Update Posted:
    Jan 25, 2022
    Last Verified:
    Jan 1, 2022