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This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.
This is an open-label study with a pre-post design. Pre-release opioid-dependent subjects from 4 Baltimore, MD area prisons (three for men and one for women) will receive 1 injection of VIVITROL prior to release from prison and will be offered 6 monthly injections of VIVITROL for 6 months post release. Subjects will complete follow-up visits 1 and 2 months after the last VIVITROL injection. Subjects will be assessed at 10 time points, and adherence to VIVITROL, both in prison and in the community, will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIVITROL | Experimental | 380 mg IM injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIVITROL 380mg | Drug | 380 mg IM injection given once monthly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Subject Re-arrest | Subjects were considered to have had a re-arrest for any new crime or probation/parole violation if the subject had re-arrest records in the official criminal justice records and/or via self-report. | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Subject Re-incarceration | Subjects were considered to have had a re-incarceration, a sentence to jail and/or prison, if the subject had re-incarceration records in the official criminal justice records and/or via self-report. | 7 months |
| Opioid Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard L Silverman, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friends Research Institute | Baltimore | Maryland | 21201 | United States |
Eligible subjects had a diagnosis of opioid dependence, were seeking treatment, and were eligible for release from prison within 30 days from screening.
Pre-release opioid-dependent subjects from 4 Baltimore, MD area prisons (3 for men and 1 for women) received 1 injection of VIVITROL prior to release from prison and were offered 6 monthly injections of VIVITROL after release from prison, for a total of 7 injections.
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| ID | Title | Description |
|---|---|---|
| FG000 | VIVITROL | 380 mg IM injection VIVITROL 380mg: 380 mg IM injection given once monthly |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects who received at least 1 injection of VIVITROL
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| ID | Title | Description |
|---|---|---|
| BG000 | VIVITROL | 380 mg IM injection VIVITROL 380mg: 380 mg IM injection given once monthly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Incidence of Subject Re-arrest | Subjects were considered to have had a re-arrest for any new crime or probation/parole violation if the subject had re-arrest records in the official criminal justice records and/or via self-report. | All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data | Posted | Number | participants re-arrested | 7 months |
|
Data were collected during a 9-month time frame
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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 | VIVITROL | 380 mg IM injection VIVITROL 380mg: 380 mg IM injection given once monthly |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
The outcome measure of opioid dependence was not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernard L. Silverman, MD | Alkermes | 781-609-6000 | Bernard.Silverman@alkermes.com |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000624616 | vivitrol |
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Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test. |
| 7 months |
| Opioid Overdose | Number of subjects who overdosed during the study; measured through reported AEs of "overdose" and Opiate Overdose Form. The Form asks subjects if subjects overdosed during the past 30 days and, if so, how many times. | 7 months |
| Drug Abuse Treatment Program Entry | Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form. | 7 months |
| Retention in the Community | Number of subjects who received all 6 post-release VIVITROL injections | 6 months |
| Opioid Craving | Change from baseline in peak craving score 30 days post last injection; assessed using a 100 mm visual analog scale (VAS). Subjects are asked to make 1 slash mark through a point on a 100 mm line that best describes their greatest craving for opioids, whereby 0 represents no craving and 100 is more than ever. | 8 months |
| Opioid Dependence | Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence | 7 months |
| Cocaine Use | Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests | 6 months |
| Criminal Activity | Number of subjects who conducted any criminal activity during the study; assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires | 6 months |
| Withdrawal by Subject |
|
| Incarcerated |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Incidence of Subject Re-incarceration | Subjects were considered to have had a re-incarceration, a sentence to jail and/or prison, if the subject had re-incarceration records in the official criminal justice records and/or via self-report. | All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data | Posted | Number | participants re-incarcerated | 7 months |
|
|
|
|
| Secondary | Opioid Use | Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test. | All subjects with non-missing data who had at least 1 injection of VIVITROL; 1 subject did not have any outcome data | Posted | Number | participants with positive opioid use | 7 months |
|
|
|
|
| Secondary | Opioid Overdose | Number of subjects who overdosed during the study; measured through reported AEs of "overdose" and Opiate Overdose Form. The Form asks subjects if subjects overdosed during the past 30 days and, if so, how many times. | All subjects who received at least 1 injection of VIVITROL | Posted | Number | participants who overdosed | 7 months |
|
|
|
| Secondary | Drug Abuse Treatment Program Entry | Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form. | All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data | Posted | Number | participants who entered drug treatment | 7 months |
|
|
|
| Secondary | Retention in the Community | Number of subjects who received all 6 post-release VIVITROL injections | All subjects who received at least 1 injection of VIVITROL | Posted | Number | participants received all 7 injections | 6 months |
|
|
|
| Secondary | Opioid Craving | Change from baseline in peak craving score 30 days post last injection; assessed using a 100 mm visual analog scale (VAS). Subjects are asked to make 1 slash mark through a point on a 100 mm line that best describes their greatest craving for opioids, whereby 0 represents no craving and 100 is more than ever. | All subjects with non-missing data who received at least 1 injection of VIVITROL | Posted | Mean | Standard Deviation | units on a scale | 8 months |
|
|
|
| Secondary | Opioid Dependence | Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence | Not Posted | 7 months |
| Secondary | Cocaine Use | Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests | All subjects with non-missing data who received at least 1 injection of VIVITROL | Posted | Number | participants who used cocaine | 6 months |
|
|
|
|
| Secondary | Criminal Activity | Number of subjects who conducted any criminal activity during the study; assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires | All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data | Posted | Number | participants with criminal activity | 6 months |
|
|
|
| 6 |
| 27 |
| 26 |
| 27 |
| Hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Schizophrenia, paranoid type | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site nodule | General disorders | MedDRA | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Urine analysis abnormal | Investigations | MedDRA | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| CSF specific gravity increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Urine ketone body present | Investigations | MedDRA | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Drug withdrawal syndrome | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
A copy of such disclosure must be given to Alkermes for review at least 60 days prior to submission for publication. Revision to such disclosure will be negotiated in good faith by the Institution, Principal Investigator, and Alkermes. The disclosure may be submitted for publication or presented by the Institution and Principal Investigator only following receipt of written notice from an authorized representative of Alkermes stating that the disclosure has been reviewed and approved.