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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA033391 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual (TAU).
This proposed study is a 6-month, two-group randomized clinical trial of XR-NTX v. TAU for 340 opioid-dependent youth ages 15-21. The study will be conducted at Mountain Manor Treatment Center, a community drug treatment program in Baltimore. TAU will consist of buprenorphine treatment of opioid withdrawal followed by counseling with or without continued buprenorphine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Release Naltrexone | Experimental | Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX [Vivitrol®] at a dose of 4cc (380mg of naltrexone)] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment. |
|
| Treatment as Usual | Active Comparator | Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended Release Naltrexone | Drug | naltrexone for extended release injectable suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use at 6 Month Follow-up | To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of opioid use at 6-months post-treatment entry. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Retention | To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of days in treatment. Treatment defined as medications for OUD received in past 30 days at 6-month follow-up. | 6 months |
| Monetized Healthcare Utilization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon G Mitchell, PhD | Friends Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friends Research Institute | Baltimore | Maryland | 21201 | United States | ||
| Mountain Manor Treatment Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended Release Naltrexone | Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX [Vivitrol®] at a dose of 4cc (380mg of naltrexone)] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment. Extended Release Naltrexone: naltrexone for extended release injectable suspension Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community. |
| FG001 | Treatment as Usual | Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment. Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community. Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended Release Naltrexone | Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX [Vivitrol®] at a dose of 4cc (380mg of naltrexone)] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment. Extended Release Naltrexone: naltrexone for extended release injectable suspension Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community. |
| 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 | Opioid Use at 6 Month Follow-up | To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of opioid use at 6-months post-treatment entry. | Posted | Mean | Standard Error | days | 6 months |
|
6 months
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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 | Extended Release Naltrexone | Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX [Vivitrol®] at a dose of 4cc (380mg of naltrexone)] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment. Extended Release Naltrexone: naltrexone for extended release injectable suspension Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Hepatitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
There was poor participant adherence to receiving the randomly assigned condition prior to inpatient discharge. For this reason, great caution is urged in interpreting outcomes based on study condition as assigned.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shannon Gwin Mitchell | Friends Research Institute | 410-837-3977 | 238 | smitchell@friendsresearch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 11, 2016 | Mar 27, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 12, 2019 | May 21, 2021 | SAP_001.pdf |
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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 |
|---|---|
| C000624616 | vivitrol |
| D002047 | Buprenorphine |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Psychosocial Treatment | Behavioral | Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community. |
|
| Buprenorphine | Drug | Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study. |
|
|
The cost-effectiveness will be assessed using the Economic Form 90 to collect data on economic outcomes of health utilization at 6 months. |
| 6 months |
| HIV Sex Risk Behaviors | To examine the impact of XR-NTX on HIV sex-risk behaviors at 6 months. Past 90 days self-reported HIV sex risk behaviors on the Risk Assessment Battery (RAB). Minimum value 0; maximum value 24. Higher scores reflect endorsement of more risk behaviors (worse outcome). | 6 months |
| Baltimore |
| Maryland |
| 21229 |
| United States |
| Withdrawal by Subject |
|
| BG001 | Treatment as Usual | Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment. Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community. Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study. |
| BG002 | Total | Total of all reporting groups |
| 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 | Count of Participants | Participants |
|
| Self-reported opioid use past 90 days | Mean | Standard Deviation | days |
|
| OG001 | Treatment as Usual | Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment. Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community. Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study. |
|
|
| Secondary | Treatment Retention | To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of days in treatment. Treatment defined as medications for OUD received in past 30 days at 6-month follow-up. | Participants who completed 6-month follow-up assessment with complete data. | Posted | Mean | Standard Deviation | days | 6 months |
|
|
|
|
| Secondary | Monetized Healthcare Utilization | The cost-effectiveness will be assessed using the Economic Form 90 to collect data on economic outcomes of health utilization at 6 months. | Posted | Mean | Standard Error | dollars | 6 months |
|
|
|
| Secondary | HIV Sex Risk Behaviors | To examine the impact of XR-NTX on HIV sex-risk behaviors at 6 months. Past 90 days self-reported HIV sex risk behaviors on the Risk Assessment Battery (RAB). Minimum value 0; maximum value 24. Higher scores reflect endorsement of more risk behaviors (worse outcome). | Participants who completed 6-month follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 1 |
| 144 |
| 5 |
| 144 |
| 132 |
| 144 |
| EG001 | Treatment as Usual | Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment. Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community. Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study. | 0 | 144 | 5 | 144 | 122 | 144 |
| Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Amputation | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Mood Instability | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Epidural Hematoma | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Seizure | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypoglycemia | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hematochezia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Root Canal Infection | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hot flush | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Injection site mass | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dark urine | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hepatitis C | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Liver function test | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Multiple Allergies | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Amputation | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Athralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Foot fracture | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ligament Sprain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tingling in arm | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cold stimulus headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Epidural Hemorrage | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Unintended Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Drug withdrawal syndrome | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Acute intoxication | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hospitalized for observation | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Intentional Self Injury | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pyelonephritis | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Formication | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Contusion | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Epistaxis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
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| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009270 | Naloxone |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |