Biomarkers of Injectable Extended Release Naltrexone Treatment
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|ClinicalTrials.gov Identifier: NCT02324725|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2014
Last Update Posted : May 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heroin Dependence Opioid Dependence||Drug: Naltrexone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biomarkers of Disease and Response to Treatment in Opioid Addiction|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2022|
Experimental: Naltrexone Intervention
Eligible participants receive up to three monthly injections of 380 mg of naltrexone contained in dissolvable polymer microspheres and administered by deep intramuscular injection and slowly released over a period of approximately 4 weeks.
Up to three monthly injections of 380 mg of naltrexone suspended in dissolvable polymer microspheres and administered intramuscularly
Other Name: Vivitrol ®
- Brain response to heroin-related visual cues [ Time Frame: 1 hour ]Brain, behavioral and motivational (e.g. craving) response to audiovisual drug-related and control stimuli (images, smells and sounds) and to standard tasks of decision making, self-appraisal, response inhibition, social interaction and reward processing.
- Cigarettes smoked per day [ Time Frame: 6 months ]behavioral
- Urine toxicology [ Time Frame: 6 months ]Urine toxicology for methamphetamine, amphetamines, cannabis, cocaine, oxycodone, buprenophine, methadone, opioids, benzodiazepines and barbiturates.
- Injections [ Time Frame: 3 months ]Number of injections (maximum of 3) accepted by participants
- Motivational response to opioid-related visual cues measured by self-reported craving for opioids [ Time Frame: 2 hours ]Change in self-reported craving for opioids after exposure to opioid-related visual cues during functional MRI sessions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324725
|United States, Pennsylvania|
|Center for the Studies of Addiction|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Daniel Langleben, MD||Co-Investigator|