Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-04 @ 7:54 PM
Study NCT ID:
NCT00218361
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2005-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Post-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006556', 'term': 'Heroin Dependence'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004091', 'term': 'Hydromorphone'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-01', 'studyFirstSubmitDate': '2005-09-16', 'studyFirstSubmitQcDate': '2005-09-16', 'lastUpdatePostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Behavioral economics', 'Drug self administration', 'Opioid'], 'conditions': ['Heroin Dependence', 'Opioid-Related Disorders']}, 'referencesModule': {'references': [{'pmid': '25911999', 'type': 'DERIVED', 'citation': 'Woodcock EA, Lundahl LH, Burmeister M, Greenwald MK. Functional mu opioid receptor polymorphism (OPRM1 A(118) G) associated with heroin use outcomes in Caucasian males: A pilot study. Am J Addict. 2015 Jun;24(4):329-35. doi: 10.1111/ajad.12187. Epub 2015 Apr 24.'}, {'pmid': '25630964', 'type': 'DERIVED', 'citation': 'Stoltman JJ, Woodcock EA, Lister JJ, Greenwald MK, Lundahl LH. Exploration of the telescoping effect among not-in-treatment, intensive heroin-using research volunteers. Drug Alcohol Depend. 2015 Mar 1;148:217-20. doi: 10.1016/j.drugalcdep.2015.01.010. Epub 2015 Jan 19.'}, {'pmid': '22339949', 'type': 'DERIVED', 'citation': 'Greenwald MK, Steinmiller CL, Sliwerska E, Lundahl L, Burmeister M. BDNF Val(66)Met genotype is associated with drug-seeking phenotypes in heroin-dependent individuals: a pilot study. Addict Biol. 2013 Sep;18(5):836-45. doi: 10.1111/j.1369-1600.2011.00431.x. Epub 2012 Feb 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether knowledge of post-session hydromorphone (HYD) availability reduces drug seeking behavior in heroin dependent individuals.', 'detailedDescription': 'Drug dependence is often characterized by severe drug seeking behavior. Learning to understand, predict, and control this maladaptive choice behavior may lead to improved prevention and treatment strategies. HYD is a drug that is currently used as a cough suppressant and to relieve pain. The purpose of this study is to determine the extent to which opioid drug seeking behavior by heroin dependent individuals can be reduced by environmental factors, including supplemental opioid drug availability, drug price, and alternative non-drug reinforcers. Specifically, this study will determine whether knowledge of post-session HYD availability influences drug seeking behavior in heroin dependent individuals, who are maintained on buprenorphine during their participation.\n\nParticipants in this observational study will take part in multiple trials in which they have the opportunity to choose either HYD or money. On the first two experimental days, prior to choice sessions, participants will receive a sample of the drug doses that can be chosen. During test sessions, participants will have 12 opportunities to choose either drug or money. Participants will use a computer to earn choices. Respiration rate, oxygen saturation, heart rate, and blood pressure will be monitored throughout choice trials. Supplemental HYD will be made available following some choice sessions. Self-report questionnaires will be completed at different times during the study. Participants will be maintained on buprenorphine throughout the study, with a minimum 2-week lead before the experiment, and a fixed 3-week detoxification after study completion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Heroin dependent research volunteers', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Opioid dependent, as determined by the structured clinical interview for DSM-IV (SCID) and Addiction Severity Index (ASI)\n* Positive urine test for opiates\n* Willing to use an adequate form of contraception for the duration of the study\n* Reads and writes English\n\nExclusion Criteria:\n\n* Psychiatric illness, as determined by the DSM-IV criteria\n* History of or current neurological disease, including structural abnormalities, seizures, infection, peripheral neuropathy, and head traumas\n* History of cardiovascular disease, myocardial infarction, chest pain, or edema\n* Systolic blood pressure greater than 160 mm Hg or less than 95 mm Hg; PR diastolic blood pressure greater than 95 mm Hg\n* Pulmonary disease, including obstructive pulmonary disease, cor pulmonale, tuberculosis, and asthma\n* Systemic disease (e.g., endocrinopathies, liver or kidney failure, myxedema, hypothyroidism, Addison's disease, autoimmune disease)\n* Current alcohol or sedative drug dependence\n* Pregnant or breastfeeding\n* Currently receiving treatment for opioid dependence\n* Known phobia of injections"}, 'identificationModule': {'nctId': 'NCT00218361', 'briefTitle': 'Effects of Post-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Biobehavioral Study of Opioid Drug Seeking Behavior: Study 2', 'orgStudyIdInfo': {'id': 'NIDA-15462-2'}, 'secondaryIdInfos': [{'id': 'R01DA015462', 'link': 'https://reporter.nih.gov/quickSearch/R01DA015462', 'type': 'NIH'}, {'id': 'R01-15462-2'}, {'id': 'DPMC'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Hydromorphone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48207', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Mark Greenwald, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mark Greenwald, PhD', 'investigatorAffiliation': 'Wayne State University'}}}}