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| ID | Type | Description | Link |
|---|---|---|---|
| U10DA013045 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| The Emmes Company, LLC | INDUSTRY |
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The aim of this study is to investigate the safety and effectiveness of buprenorphine in the presence of naltrexone for the treatment of cocaine dependence.
This project will assess the utility of buprenorphine in the presence of naltrexone as a potential medication useful in reducing cocaine use, commencing a research direction of great importance to both theoretical and practical addiction medicine. Buprenorphine will be provided as sublingual buprenorphine+naloxone tablets (Suboxone®, "BUP"). Naltrexone will be provided as extended-release (XR) naltrexone by injection (Vivitrol®, "XR-NTX").
In this multi-center, double-blind, placebo-controlled trial, participants will randomly assigned to one of three medication conditions: 4mg buprenorphine plus naltrexone (BUP4+XR-NTX), 16mg buprenorphine plus naltrexone (BUP16+XR-NTX), or placebo plus naltrexone (PLB+XR-NTX) for 8 weeks of treatment. Participants will be scheduled for clinic visits three times weekly (for a total of 24 visits across the 8-week treatment period) for observed medication administration, provision of take-home medication, collection of safety, medical, drug use, psychological, and compliance measures. In addition, all participants will be scheduled for once-weekly individual Cognitive Behavioral Therapy (CBT) sessions.
This protocol will explore the effects of these three medication conditions to test buprenorphine as a possible treatment for cocaine dependence. This study will advance the science, provide dosing information, and characterize the effects of the combination of the two medications in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BUP4+XR-NTX | Experimental | 4mg buprenorphine plus naltrexone for 8 weeks of treatment |
|
| BUP16+XR-NTX | Experimental | 16mg buprenorphine plus naltrexone for 8 weeks of treatment |
|
| PLB+XR-NTX | Active Comparator | naltrexone for 8 weeks of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine + Naltrexone | Drug | Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens | Self-reported days of cocaine use corroborated with urine drug screens (UDS). | final 30 days of Treatment Phase, study days 25-54 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter Ling, M.D. | University of California, Los Angeles | Principal Investigator |
| Andrew J. Saxon, M.D. | VA Puget Sound Health Care System | Principal Investigator |
| Larissa J. Mooney, M.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Integrated Substance Abuse Programs (ISAP) | Los Angeles | California | 90025 | United States | ||
| Bay Area Addiction Research and Treatment (BAART) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26948856 | Result | Ling W, Hillhouse MP, Saxon AJ, Mooney LJ, Thomas CM, Ang A, Matthews AG, Hasson A, Annon J, Sparenborg S, Liu DS, McCormack J, Church S, Swafford W, Drexler K, Schuman C, Ross S, Wiest K, Korthuis PT, Lawson W, Brigham GS, Knox PC, Dawes M, Rotrosen J. Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence: the Cocaine Use Reduction with Buprenorphine (CURB) study. Addiction. 2016 Aug;111(8):1416-27. doi: 10.1111/add.13375. Epub 2016 Apr 21. | |
| 23159524 |
| Label | URL |
|---|---|
| National Institute on Drug Abuse Clinical Trials Network Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | BUP4+XR-NTX | 4mg buprenorphine plus naltrexone for 8 weeks of treatment |
| FG001 | BUP16+XR-NTX | 16mg buprenorphine plus naltrexone for 8 weeks of treatment |
| FG002 | PLB+XR-NTX | Placebo plus naltrexone for 8 weeks of treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | BUP4+XR-NTX | 4mg buprenorphine plus naltrexone for 8 weeks of treatment |
| BG001 | BUP16+XR-NTX | 16mg buprenorphine plus naltrexone for 8 weeks of treatment |
| 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 | Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens | Self-reported days of cocaine use corroborated with urine drug screens (UDS). | Posted | Mean | Standard Deviation | days of cocaine use | final 30 days of Treatment Phase, study days 25-54 |
|
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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 | BUP4+XR-NTX | 4mg buprenorphine plus naltrexone for 8 weeks of treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Walter Ling, MD | UCLA Integrated Substance Abuse Programs | 310-267-5888 | lwalter@ucla.edu |
Not provided
| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D019966 | Substance-Related Disorders |
| D009293 | Opioid-Related Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
| D003192 | Compulsive Behavior |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009271 | Naltrexone |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| C000624616 | vivitrol |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
|
| Placebo + Naltrexone | Drug | Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels. |
|
|
| San Francisco |
| California |
| 94102 |
| United States |
| Addiction Research and Treatment Services (ARTS) | Denver | Colorado | 80206 | United States |
| Howard University Hospital | Washington D.C. | District of Columbia | 20060 | United States |
| Atlanta VA Medical Center | Atlanta | Georgia | 30345 | United States |
| Bellevue Hospital Center | New York | New York | 10016 | United States |
| Albert Einstein College of Medicine - Division of Substance Abuse | The Bronx | New York | 10461 | United States |
| Maryhaven | Columbus | Ohio | 43207 | United States |
| CODA, Inc. | Portland | Oregon | 97214 | United States |
| South Texas Veterans Health Care System | San Antonio | Texas | 78229 | United States |
| Recovery Centers of King County (RCKC) | Seattle | Washington | 98122 | United States |
| Mooney LJ, Nielsen S, Saxon A, Hillhouse M, Thomas C, Hasson A, Stablein D, McCormack J, Lindblad R, Ling W. Cocaine use reduction with buprenorphine (CURB): rationale, design, and methodology. Contemp Clin Trials. 2013 Mar;34(2):196-204. doi: 10.1016/j.cct.2012.11.002. Epub 2012 Nov 16. |
| Clinical Trials Network Dissemination Library Website | View source |
| UCLA Integrated Substance Abuse Programs Website | View source |
| Physician Decision |
|
| Incarcerated (N=3) |
|
| BG002 | PLB+XR-NTX | Placebo plus naltrexone for 8 weeks of treatment |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Age, Customized | Number | 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 |
|
Placebo plus naltrexone for 8 weeks of treatment
|
|
| 13 |
| 100 |
| 66 |
| 100 |
| EG001 | BUP16+XR-NTX | 16mg buprenorphine plus naltrexone for 8 weeks of treatment | 8 | 100 | 64 | 100 |
| EG002 | PLB+XR-NTX | Placebo plus naltrexone for 8 weeks of treatment | 12 | 102 | 61 | 102 |
| Suicidal Ideation | Psychiatric disorders |
|
| Suicidal Behavior | Psychiatric disorders |
|
| Psychotic Disorder | Psychiatric disorders |
|
| Major Depression | Psychiatric disorders |
|
| Pancreatitis | Gastrointestinal disorders |
|
| Oesophagitis | Gastrointestinal disorders |
|
| Haematemesis | Gastrointestinal disorders |
|
| Gastric Ulcer Perforation | Gastrointestinal disorders |
|
| Gastric Ulcer | Gastrointestinal disorders |
|
| Diverticulum | Gastrointestinal disorders |
|
| Drug Detoxification | Surgical and medical procedures |
|
| Dialysis | Surgical and medical procedures |
|
| Sinusitis | Infections and infestations |
|
| Wound Infection Staphylococcal | Infections and infestations |
|
| Cellulitis | Infections and infestations |
|
| Chest Pain | General disorders |
|
| Non-Cardiac Chest Pain | General disorders |
|
| Cardiac Death | General disorders |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders |
|
| Asthma | Respiratory, thoracic and mediastinal disorders |
|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Metastases to Spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders |
|
| International Normalised Ratio Increased | Investigations |
|
| Toxicity to Various Agents | Injury, poisoning and procedural complications |
|
| Acute Febrile Neutrophilic Dermatosis | Skin and subcutaneous tissue disorders |
|
| Nephrolithiasis | Renal and urinary disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Dry Mouth | Gastrointestinal disorders |
|
| Abdominal Pain | Gastrointestinal disorders |
|
| Toothache | Gastrointestinal disorders |
|
| Abdominal Discomfort | Gastrointestinal disorders |
|
| Abdominal Pain Upper | Gastrointestinal disorders |
|
| Diverticulum | Gastrointestinal disorders |
|
| Dental Caries | Gastrointestinal disorders |
|
| Sensitivity of Teeth | Gastrointestinal disorders |
|
| Abdominal Distension | Gastrointestinal disorders |
|
| Retching | Gastrointestinal disorders |
|
| Peptic Ulcer | Gastrointestinal disorders |
|
| Pancreatitis | Gastrointestinal disorders |
|
| Oesophagitis | Gastrointestinal disorders |
|
| Haematemesis | Gastrointestinal disorders |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders |
|
| Gastrointestinal Ulcer | Gastrointestinal disorders |
|
| Gastric Ulcer Perforation | Gastrointestinal disorders |
|
| Gastric Ulcer | Gastrointestinal disorders |
|
| Faeces Hard | Gastrointestinal disorders |
|
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Somnolence | Nervous system disorders |
|
| Tremor | Nervous system disorders |
|
| Sedation | Nervous system disorders |
|
| Loss of Consciousness | Nervous system disorders |
|
| Dysgeusia | Nervous system disorders |
|
| Sciatica | Nervous system disorders |
|
| Paraesthesia | Nervous system disorders |
|
| Lethargy | Nervous system disorders |
|
| Hypoaesthesia | Nervous system disorders |
|
| Depressed Level of Consciousness | Nervous system disorders |
|
| Tension Headache | Nervous system disorders |
|
| Aura | Nervous system disorders |
|
| Parosmia | Nervous system disorders |
|
| Insomnia | Psychiatric disorders |
|
| Depression | Psychiatric disorders |
|
| Anxiety | Psychiatric disorders |
|
| Libido Decreased | Psychiatric disorders |
|
| Suicidal Ideation | Psychiatric disorders |
|
| Euphoric Mood | Psychiatric disorders |
|
| Depressed Mood | Psychiatric disorders |
|
| Sleep Disorder | Psychiatric disorders |
|
| Restlessness | Psychiatric disorders |
|
| Intentional Self-injury | Psychiatric disorders |
|
| Drug Dependence | Psychiatric disorders |
|
| Disorentation | Psychiatric disorders |
|
| Suicidal Behavior | Psychiatric disorders |
|
| Substance-induced Mood Disorder | Psychiatric disorders |
|
| Psychotic Disorder | Psychiatric disorders |
|
| Panic Attack | Psychiatric disorders |
|
| Nervousness | Psychiatric disorders |
|
| Mental Status Changes | Psychiatric disorders |
|
| Major Depression | Psychiatric disorders |
|
| Fatigue | General disorders |
|
| Drug Withdrawal Syndrome | General disorders |
|
| Irritability | General disorders |
|
| Chest Pain | General disorders |
|
| Non-cardiac Chest Pain | General disorders |
|
| Influenza-like Illness | General disorders |
|
| Sluggishness | General disorders |
|
| Asthenia | General disorders |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders |
|
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders |
|
| Limb Discomfort | Musculoskeletal and connective tissue disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| Tooth Abscess | Infections and infestations |
|
| Sinusitis | Infections and infestations |
|
| Upper Respiratory Tract Infection | Infections and infestations |
|
| Tooth Infection | Infections and infestations |
|
| Periorbital Infection | Infections and infestations |
|
| Haemophilus Infection | Infections and infestations |
|
| Cellulitis | Infections and infestations |
|
| Wound Infection Staphylococcal | Infections and infestations |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Cold Sweats | Skin and subcutaneous tissue disorders |
|
| Night Sweats | Skin and subcutaneous tissue disorders |
|
| Acute Febrile Neutrophilic Dermatosis | Skin and subcutaneous tissue disorders |
|
| Astma | Respiratory, thoracic and mediastinal disorders |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders |
|
| Pulmonary Congestion | Respiratory, thoracic and mediastinal disorders |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders |
|
| Decreased Appetitie | Metabolism and nutrition disorders |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Hypokalaemia | Metabolism and nutrition disorders |
|
| Laceration | Injury, poisoning and procedural complications |
|
| Toxicity to Various Agents | Injury, poisoning and procedural complications |
|
| Thermal Burn | Injury, poisoning and procedural complications |
|
| Post-traumatic Neck Syndrome | Injury, poisoning and procedural complications |
|
| Post-lumbar Puncture Syndrome | Injury, poisoning and procedural complications |
|
| Joint Dislocation | Injury, poisoning and procedural complications |
|
| Fall | Injury, poisoning and procedural complications |
|
| Ankle Fracture | Injury, poisoning and procedural complications |
|
| Alcohol Poisoning | Injury, poisoning and procedural complications |
|
| Drug Detoxification | Surgical and medical procedures |
|
| Tooth Extraction | Surgical and medical procedures |
|
| Dialysis | Surgical and medical procedures |
|
| Weight Increased | Investigations |
|
| Urine Analysis Abnormal | Investigations |
|
| Liver Function Test Abnormal | Investigations |
|
| International Normalized Ratio Increased | Investigations |
|
| Blood Pressure Increased | Investigations |
|
| Hot Flush | Vascular disorders |
|
| Hypertensive Crisis | Vascular disorders |
|
| Hypertension | Vascular disorders |
|
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Metastases to Spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Lung Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Seasonal Allergy | Immune system disorders |
|
| Hypersensitivity | Immune system disorders |
|
| Tinnitus | Ear and labyrinth disorders |
|
| Ear Pain | Ear and labyrinth disorders |
|
| Ear Discomfort | Ear and labyrinth disorders |
|
| Urinary Retention | Renal and urinary disorders |
|
| Nephrolithiasis | Renal and urinary disorders |
|
| Dysuria | Renal and urinary disorders |
|
| Cholelithiasis | Hepatobiliary disorders |
|
| Lacrimation Increased | Eye disorders |
|
| Hyperthyrodism | Endocrine disorders |
|
| Adrenal Mass | Endocrine disorders |
|
| Neutropenia | Blood and lymphatic system disorders |
|
| Monocytosis | Blood and lymphatic system disorders |
|
The sponsor can review results communications prior to public release and can embargo communications regarding trial results. The sponsor can require changes to the communication and can extend the embargo.
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| 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 |