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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA017904 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Massachusetts General Hospital | OTHER |
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This study is designed to evaluate the relative efficacy of a novel treatment (CBT-IC) versus a standard individual drug-counseling treatment. The novel treatment emphasizes exposure to emotional cues for drug use as part of a comprehensive, yet brief, treatment strategy. These treatments are delivered to opiate-dependent, often poly-substance dependent, individuals in a comprehensive methadone maintenance program who have failed to respond adequately to current treatments.
This study study is designed to test further the efficacy of Cognitive-Behavior Therapy for Interoceptive Cues (CBT-IC - a treatment with a central focus on enhancing a patient's tolerance to the myriad forms of distress-sadness, boredom, anxiety, withdrawal sensations, etc.-that are linked to the stressful lives of drug-dependent individuals, and breaking the link between these emotional cues and drug-related attempts to avoid emotional distress) for intervening with chronically-stressed and treatment-resistant opiate-dependent outpatients. Features of this study of particular relevance to to RFA DA-04-001 include: (1) a focus on opiate-dependent patients undergoing chronic stress; (2) a model for the way in which chronic stress translates into chronic drug use; (2) a focus on the way in which stress-related symptoms serve as trigger for drug use; (3) a focus on both mediators and moderators of treatment that will inform treatment-matching efforts, including a focus on gender differences and emotional avoidance/distress intolerance; and (4) the examination of treatment outcome in a Stage II treatment trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cognitive Behavioral Therapy |
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| 2 | Active Comparator | Individual Counseling |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | 12 weekly sessions and 3 booster sessions of cognitive behavioral therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Positive Toxicology Swabs for Illicit Substances | The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates. | Weekly assessments with summation over three time periods: baseline, treatment, and eight weeks of follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Addiction Severity Index (ASI) Drug Composite Index | The composite score for drug use is determined by answers to 13 questions on the ASI: A/390 + B/390 + C/390 + D/390 + E/390 + F/390 + G/390 +H/390 + I/390 + J/390 + K/390 + L/52 + M/52. A single score is provided, with possible scores ranging from 0 to 1, with higher scores indicate greater drug use. | Baseline, Mid Treatment, Treatment Endpoint, Follow-up Evaluation 1, Follow-up Evaluation 2 |
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Inclusion Criteria:
The primary selection criteria include women and men between the ages of 18 and 65 who:
Meet DSM-IV criteria for opiate dependence,
Maintain a stable dose of methadone for two weeks prior to recruitment and,
a) fail to achieve "take-home" status for methadone dosing during at least the first four months of methadone treatment, b) test positive on at least two toxicology screens for illicit drugs during the month prior to recruitment c) have never achieved two consecutive toxicology screens free of illicit substances since entering the current treatment episode.
Meet study criteria for chronic stress
Exclusion Criteria:
(1) Patients with significantly unstable or uncontrolled medical illness which may interfere with participation in treatment (e.g., patients likely to require hospitalization during the study period).
(2) Patients with a psychotic or organic mental disorder according to DSM-IV criteria.
(3) Patients receiving medication affecting methadone metabolism (e.g. rifampin).
(4) Patients with uncontrolled bipolar disorder as evidenced by meeting current criteria for mania or hypomania or meeting criteria for rapid cycling in the last year (as indicated by structured questioning of all patients meeting criteria for bipolar disorder).
(5) Patients unable to complete the informed consent or unable to understand study procedures in the informed consent process.
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| Name | Affiliation | Role |
|---|---|---|
| Michael W. Otto, Ph.D. | Boston University | Principal Investigator |
| Mark H. Pollack, M.D. | Rush University | Principal Investigator |
| Steven A. Safren, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bay Cove Treatment Center | Boston | Massachusetts | 02114 | United States | ||
| Habit Management Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21090958 | Background | Hearon BA, Calkins AW, Halperin DM, McHugh RK, Murray HW, Otto MW. Anxiety sensitivity and illicit sedative use among opiate-dependent women and men. Am J Drug Alcohol Abuse. 2011 Jan;37(1):43-7. doi: 10.3109/00952990.2010.535581. Epub 2010 Nov 19. | |
| 23398222 | Result | McHugh RK, Murray HW, Hearon BA, Pratt EM, Pollack MH, Safren SA, Otto MW. Predictors of dropout from psychosocial treatment in opioid-dependent outpatients. Am J Addict. 2013 Jan;22(1):18-22. doi: 10.1111/j.1521-0391.2013.00317.x. |
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133 individuals were consented. Eleven dropped out prior to SCID administration. At the intake visit, 27 individuals were deemed ineligible. Of the 95 individuals who were eligible, 17 dropped out prior to randomization (7 were discharged, 2 declined treatment, and 8 were lost to contact). A total of 78 individuals were randomized to treatment.
Participants were recruited via study flyers and postings or were referred to study staff by their substance abuse counselor.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral Therapy | Cognitive Behavioral Therapy Cognitive Behavioral Therapy: 12 weekly sessions and 3 booster sessions of cognitive behavioral therapy |
| FG001 | Individual Drug Counseling | Individual Drug Counseling Individual Counseling: 12 weekly sessions and 3 booster sessions of individual counseling |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Completed Treatment |
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| Completed 2 Follow-Up Visits |
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Randomized sample
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavior Therapy | Psychosocial treatment with an individualized therapy emphasizing interoceptive exposure and training alternative responses to cues for drug use |
| BG001 | Individual Drug Counseling |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Positive Toxicology Swabs for Illicit Substances | The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates. | Randomized participants | Posted | Mean | Standard Deviation | percentage of positive toxicology screen | Weekly assessments with summation over three time periods: baseline, treatment, and eight weeks of follow-up. |
|
Adverse event data were not formally collected. However, any informal report via a participant was recorded from the initial baseline session to the two follow-up assessments. All-cause mortality was not assessed.
Because the study involved staff from both Boston University and Massachusetts General Hospital, participants signed a consent form for each institution. Subsequently, all serious adverse events (SAEs) were reported to the IRBs of both institutions. All SAEs were reported within 24 hours of discovery. SAE reports were collected in a non-systematic matter and all were judged by the investigators to be unrelated to the study procedures.
Adverse events (AEs) were not assessed in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Behavioral Therapy | Cognitive Behavioral Therapy Cognitive Behavioral Therapy: 12 weekly sessions and 3 booster sessions of cognitive behavioral therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot Ulcer | General disorders | Non-systematic Assessment | A participant was hospitalized for a chronic foot ulcer problem. Hospitalization lasted for two weeks, but the participant still completed his study visits. The medical event was judged to be in no way related to the study procedures. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael W. Otto, Ph.D. | Boston University Charles River Campus | (617)353-9610 | mwotto@bu.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Individual Counseling | Behavioral | 12 weekly sessions and 3 booster sessions of individual counseling |
|
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| Boston |
| Massachusetts |
| 02118 |
| United States |
| 23061323 | Result | McHugh RK, Weitzman M, Safren SA, Murray HW, Pollack MH, Otto MW. Sexual HIV risk behaviors in a treatment-refractory opioid-dependent sample. J Psychoactive Drugs. 2012 Jul-Aug;44(3):237-42. doi: 10.1080/02791072.2012.703507. |
| 25364993 | Result | Otto MW, Hearon BA, McHugh RK, Calkins AW, Pratt E, Murray HW, Safren SA, Pollack MH. A randomized, controlled trial of the efficacy of an interoceptive exposure-based CBT for treatment-refractory outpatients with opioid dependence. J Psychoactive Drugs. 2014 Nov-Dec;46(5):402-11. doi: 10.1080/02791072.2014.960110. |
| Completed ASI at Follow-Up #2 |
|
| COMPLETED |
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| NOT COMPLETED |
|
Psychosocial treatment with individual drug counseling
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Individual Drug Counseling | Individual Drug Counseling Individual Counseling: 12 weekly sessions and 3 booster sessions of individual counseling |
|
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| Secondary | Addiction Severity Index (ASI) Drug Composite Index | The composite score for drug use is determined by answers to 13 questions on the ASI: A/390 + B/390 + C/390 + D/390 + E/390 + F/390 + G/390 +H/390 + I/390 + J/390 + K/390 + L/52 + M/52. A single score is provided, with possible scores ranging from 0 to 1, with higher scores indicate greater drug use. | Randomized participants | Posted | Mean | Standard Deviation | units on a scale | Baseline, Mid Treatment, Treatment Endpoint, Follow-up Evaluation 1, Follow-up Evaluation 2 |
|
|
|
| 0 |
| 0 |
| 11 |
| 41 |
| 0 |
| 41 |
| EG001 | Individual Drug Counseling | Individual Drug Counseling Individual Counseling: 12 weekly sessions and 3 booster sessions of individual counseling | 0 | 0 | 11 | 37 | 0 | 37 |
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| Ankle Sprain | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant was partially hospitalized for a sprained left ankle. Hospitalization was required due to patient's perceived medical risk. This event was judged to be unrelated to study procedures. |
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| Kidney infection | Renal and urinary disorders | Non-systematic Assessment | Participant was hospitalized due to a kidney infection secondary to an untreated urinary tract infection. This event was judged to be unrelated to study procedures. |
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| Hairline fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant was admitted to the ER secondary to bruised ribs and hairline fracture secondary to falling from a chair. |
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| Oversedation | Psychiatric disorders | Non-systematic Assessment | Participant was hospitalized secondary to "oversedation." Patient subsequently sought out inpatient detox, complaining of overprescription of a benzodiazepine medication and acute psychiatric symptoms. |
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| Groin Injury | Renal and urinary disorders | Non-systematic Assessment | Participant was hospitalized due to problematic functioning in the patient's groin area. |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Hospitalization due to pneumonia resulting from chronic condition that compromises immune functioning. |
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| High Glucose Levels | Endocrine disorders | Non-systematic Assessment | Hospitalization due to extremely high glucose levels resulting from diabetes. |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Participant was hospitalized for four days due to pneumonia, inflamed intestines, and high blood pressure (as per patient report). Investigators learned about the SAE after patient has been discharged. |
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| Respiratory Problems | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Hospitalization due to low blood pressure and respiratory problems. |
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| Detoxification | Psychiatric disorders | Non-systematic Assessment | Participant reported being admitted to a residential substance abuse treatment facility for detoxification. The patient remained at the facility for 30 days. The admission to the facility occurred prior to randomization to treatment condition. |
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| Depression | Psychiatric disorders | Non-systematic Assessment | Inpatient psychiatry hospitalization for six days due to symptoms of depression. Patient denied suicidal ideation, and stated that hospitalization was required for emergency medication management. |
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| Blood Clot | Blood and lymphatic system disorders | Non-systematic Assessment | Hospitalization for five days due to formation of a blood clot around the central artery, where a central IV had previously been placed. Patient was treated by hospital staff with prescribed self-injection and a blood thinner. |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Hospitalization for seven days due to a bout of pneumonia. |
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| Hospitalization for Chronic Health Concerns | General disorders | Non-systematic Assessment | Hospitalization for four days. Participant had chronic health concerns and completed the active treatment phase of the study and had been discharged from the clinic before hospitalization. This SAE was unrelated to study procedures. |
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| Infection | General disorders | Non-systematic Assessment | Hospitalization for two to three days for an infection and unspecified chronic health problems. Participant resumed and completed study procedures upon discharge from the hospital. This event was unrelated to study procedures. |
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| Detoxification | Psychiatric disorders | Non-systematic Assessment | Participant voluntarily entered an inpatient unit for five days for the detoxification of benzodiazepines. Participant resumed and completed study procedures upon discharge from the hospital. This event was unrelated to study procedures. |
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| Detoxification | Psychiatric disorders | Non-systematic Assessment | Participant was hospitalized for detoxification and mental health problems. This participant was subsequently discharged from the methadone clinic and did not complete study procedures. This event was unrelated to study procedures. |
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| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment | Participant reported losing housing, and reported suicidal ideation to a (non-study) counselor to obtain emergency housing. Participant was at this unit for several days, yet came to the methadone clinic as part of scheduled study involvement. |
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| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment | Participant reported serious psychological distress to study staff. After assessing suicidal ideation, it was decided that this situation warranted intervention.The participant was then independently assessed and hospitalization by clinic staff. |
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| Detoxification | Psychiatric disorders | Non-systematic Assessment | Participant voluntarily entered an inpatient detoxification unit for the detoxification of heroin and benzodiazepines. Upon discharge from the detoxification facility, the participant resumed regular study involvement and completed study procedures. |
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| Detoxification | Psychiatric disorders | Non-systematic Assessment | Participant voluntarily entered an inpatient unit for 5 days for the detoxification of benzodiazepines. Upon discharge from the detoxification facility, the participant resumed regular dosing at the methadone clinic and resumed study procedures. |
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| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment | The investigators were notified that a participant was hospitalized again for suicidal ideation. The clinic staff independently assessed the patient and deemed that hospitalization was necessary. |
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| Detoxification | Psychiatric disorders | Non-systematic Assessment | Participant voluntarily entered an inpatient detoxification unit. Upon discharge from the detoxification facility, the participant resumed regular study involvement. |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Participant was hospitalized for 7 days for pneumonia. This participant has a history of chronic health problems, which worsened to the point that IV antibiotics were needed. Participant resumed dosing at the clinic and resumed study procedures. |
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| Stab Wound | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant was hospitalized for five days for various medical problems related to a stab wound, including several blood transfusions. Participant resumed dosing at the clinic and resumed study procedures. |
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| Kidney Stone | Renal and urinary disorders | Non-systematic Assessment | Participant was hospitalized for several days for a kidney stone. Participant was released and resumed dosing at the clinic and resumed study procedures. |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment | Participant hospitalized for dehydration. Following discharged, participant resumed dosing at the clinic and continued with study procedures. |
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| Wound Treatment | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant was hospitalized overnight for 3 days. Participant was beaten over the head and received treatment for his wounds at this hospital. Participant resumed dosing at the clinic and continued study procedures. |
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| Hospitalization for Chronic Health Concerns | General disorders | Non-systematic Assessment | Hospitalization for four days. Participant had chronic health concerns and completed the active treatment phase of the study and had been discharged from the clinic before hospitalization. |
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| Mid Treatment |
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| Treatment Endpoint |
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| Follow Up 1 |
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| Follow-Up 2 |
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