Depot Naltrexone Mechanism of Action in Heroin Dependent Patients Using fMRI and SPECT
NCT ID: NCT01471145
Last Updated: 2014-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2013-01-31
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The following hypotheses are tested:
* XRNT modulates the fMRI response to drug cues in predetermined brain regions.
* The expression of striatal transporters (assessed with SPECT) will decrease after a three-month course of extended release naltrexone
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade
NCT01822132
Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
NCT02437344
Addition of Naltrexone to Methadone Taper
NCT00135759
Facilitating Rapid Naltrexone Initiation
NCT03345173
Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts
NCT00142948
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Depot Naltrexone
Naltrexone
naltrexone for extended-release injectable suspension, 380 mg/vial, every 4 weeks or once a month
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Naltrexone
naltrexone for extended-release injectable suspension, 380 mg/vial, every 4 weeks or once a month
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthy controls: no diagnosis of substance dependence, no current psychotropic medication. Care will be taken to match controls for gender, age, smoking status, IQ and handedness.
Exclusion Criteria
* Medical contraindications for XRNT or MRI (Langleben 2006; Langleben, Ruparel et al. 2008). Briefly, the former include candidates with known hypersensitivity to naltrexone,PLG (poly-lactide-coglycolide), carboxymethylcellulose, or any other components of the Vivitrol® diluent, hepatic or renal disease, chronic pain syndromes, female subjects who are pregnant or lactating, or are of child bearing potential and are not using an acceptable method of birth control. MRI contraindications include chronic medical (neurological, cardiovascular, infectious, metabolic, etc) conditions that may affect the brain morphology and/or activity and indwelling foreign metallic or magnetically sensitive objects and devices, such as shrapnel, pacemakers, orthopaedic fixation devices or vascular stents
* Presence of disorders precluding normal perception of visual and auditory stimuli, such as color blindness, deafness, severe myopia, etc.
* Patients with a history of or current psychosis or current major depressive disorder with suicidal ideation
* Patients who are being treated under forced treatment conditions
* History or evidence of disorders that may affect cerebral function or circulation, such as diabetes and other metabolic disorders, encephalopathy, cardiovascular or cerebrovascular disease, history of head trauma with depressed skull fracture or prolonged loss of consciousness and history of brain surgery
* Female subjects: women who are pregnant or breast-feeding
* Current psychotropic medication
* Use of any prescription medications that could affect alertness or the circulatory system
* IQ \< 70
* Naltrexone use within the past 6 months
* Baseline aspartate aminotransferase or alanine aminotransferase more than three times the upper limit of normal
* Patients with no intention to be opioid-free for a minimum of 7 days before starting XRNT treatment
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Alkermes, Inc.
INDUSTRY
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Wim van den Brink
Prof. dr. W. van den Brink
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wim van den Brink, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Academic Medical Center
Amsterdam, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cornish JW, Metzger D, Woody GE, Wilson D, McLellan AT, Vandergrift B, O'Brien CP. Naltrexone pharmacotherapy for opioid dependent federal probationers. J Subst Abuse Treat. 1997 Nov-Dec;14(6):529-34. doi: 10.1016/s0740-5472(97)00020-2.
de Geus EJ, van't Ent D, Wolfensberger SP, Heutink P, Hoogendijk WJ, Boomsma DI, Veltman DJ. Intrapair differences in hippocampal volume in monozygotic twins discordant for the risk for anxiety and depression. Biol Psychiatry. 2007 May 1;61(9):1062-71. doi: 10.1016/j.biopsych.2006.07.026. Epub 2006 Nov 29.
Knutson B, Westdorp A, Kaiser E, Hommer D. FMRI visualization of brain activity during a monetary incentive delay task. Neuroimage. 2000 Jul;12(1):20-7. doi: 10.1006/nimg.2000.0593.
Krupitsky E, Nunes EV, Ling W, Illeperuma A, Gastfriend DR, Silverman BL. Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial. Lancet. 2011 Apr 30;377(9776):1506-13. doi: 10.1016/S0140-6736(11)60358-9.
Langleben DD, Ruparel K, Elman I, Busch-Winokur S, Pratiwadi R, Loughead J, O'Brien CP, Childress AR. Acute effect of methadone maintenance dose on brain FMRI response to heroin-related cues. Am J Psychiatry. 2008 Mar;165(3):390-4. doi: 10.1176/appi.ajp.2007.07010070. Epub 2007 Dec 3.
Lobmaier P, Kornor H, Kunoe N, Bjorndal A. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD006140. doi: 10.1002/14651858.CD006140.pub2.
Luijten M, Veltman DJ, van den Brink W, Hester R, Field M, Smits M, Franken IH. Neurobiological substrate of smoking-related attentional bias. Neuroimage. 2011 Feb 1;54(3):2374-81. doi: 10.1016/j.neuroimage.2010.09.064. Epub 2010 Oct 13.
Suh JJ, Langleben DD, Ehrman RN, Hakun JG, Wang Z, Li Y, Busch SI, O'Brien CP, Childress AR. Low prefrontal perfusion linked to depression symptoms in methadone-maintained opiate-dependent patients. Drug Alcohol Depend. 2009 Jan 1;99(1-3):11-7. doi: 10.1016/j.drugalcdep.2008.06.007. Epub 2008 Jul 31.
Suh JJ, Pettinati HM, Kampman KM, O'Brien CP. Gender differences in predictors of treatment attrition with high dose naltrexone in cocaine and alcohol dependence. Am J Addict. 2008 Nov-Dec;17(6):463-8. doi: 10.1080/10550490802409074.
Zijlstra F, Booij J, van den Brink W, Franken IH. Striatal dopamine D2 receptor binding and dopamine release during cue-elicited craving in recently abstinent opiate-dependent males. Eur Neuropsychopharmacol. 2008 Apr;18(4):262-70. doi: 10.1016/j.euroneuro.2007.11.002.
Zijlstra F, Veltman DJ, Booij J, van den Brink W, Franken IH. Neurobiological substrates of cue-elicited craving and anhedonia in recently abstinent opioid-dependent males. Drug Alcohol Depend. 2009 Jan 1;99(1-3):183-92. doi: 10.1016/j.drugalcdep.2008.07.012. Epub 2008 Sep 26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-001890-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
60-60600-97-301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.