Heroin DependenceNCT00218309
Effects of Pre-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals
An observational study of Heroin Dependence and Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the opportunity to take free supplemental hydromorphone (HYD) influences drug seeking behavior in heroin dependent individuals. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Heroin Dependence, Opioid-Related Disorders
- What is being tested?
- Hydromorphone
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jul 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current opiate dependence, verified by the structured clinical interview for DSM-IV (SCID) and Addiction Severity Index (ASI)
- Positive urine test for opiates
- Agreement to use adequate contraception for the duration of the study
- Able to read and write English
Who cannot join
- DSM-IV diagnosis of a psychiatric illness
- History of or current neurological disease, including structural brain abnormalities, seizures, infection, peripheral neuropathy, and head trauma
- History of cardiovascular disease, myocardial infarction, chest pain, edema, systolic blood pressure greater than 160 mm Hg or less than 95 mm Hg, or diastolic blood pressure greater than 95 mm Hg
- Pulmonary disease, including obstructive pulmonary disease, cor pulmonale, tuberculosis, and asthma
- Systemic diseases, such as endocrinopathies, liver or kidney failure, myxedema, hypothyroidism, Addison's disease, or autoimmune disease
- Current alcohol or sedative drug dependence
Show all 9Show fewer
- Pregnant or breastfeeding
- Currently receiving treatment for opioid dependence
- Known phobia of injections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biobehavioral Studies of Opioid Drug Seeking Behavior: Study 1
The purpose of this study is to determine whether the opportunity to take free supplemental hydromorphone (HYD) influences drug seeking behavior in heroin dependent individuals.
Read the detailed description
Drug dependence is a condition in which drug seeking holds a higher priority than behaviors controlled by other reinforcers. Learning to understand, predict, and control this maladaptive choice behavior may lead to improved prevention and treatment strategies. HYD is a drug 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 in heroin dependent individuals can be reduced by environmental factors, including supplemental opioid drug availability, drug price, and non-drug alternative reinforcers. Specifically, this study will determine whether pre-session opportunity to take "free" supplemental HYD influences HYD seeking by using a choice progressive ratio schedule as well as by varying the dose of HYD.
Participants in this observational study will undergo multiple test sessions in which they will select between acquiring drug or money. Because participants may choose money on all 12 trials of test sessions as a way to avoid receiving an injection, a placebo injection will be given when money is chosen. Prior to each test session, participants will receive a sample of the drug dose. During each test session, participants will have 12 opportunities to select either drug (administered as HYD) or money. Prior to each individual choice trial, participants will receive supplemental HYD. Participants will use a computer to earn choices. Respiration rate, oxygen saturation, heart rate, and blood pressure will be monitored throughout choice trials. Pupil diameter will be measured with a digital camera. Participants will complete self-report questionnaires at different times during the study. Participants will be maintained on buprenorphine throughout the study, with a fixed 3-week detoxification after study completion.
- Conditions
- Heroin Dependence, Opioid-Related Disorders
- Being tested
- Hydromorphone
- Keywords
- opiate dependence
- Medical subject headings
- Heroin Dependence, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heroin DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 16 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Wayne State University
- Investigators
- Mark Greenwald, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218309
- Sponsor's protocol ID
- NIDA-15462-1
- Other IDs
- R01-15462-1
- Status last verified
- May 2006
- First submitted
- 16 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
Publications
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.
PubMed 25911999Stoltman 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.
PubMed 25630964Greenwald 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.
PubMed 22339949
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Studies of Opioid Drug Seeking Behavior: Study 1
- ClinicalTrials.gov ID
- NCT00218309
- Acronym / sponsor ID
- NIDA-15462-1
- Conditions
- Heroin Dependence, Opioid-Related Disorders
- Keywords
- opiate dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- Wayne State University
- Study start
- Sep 2003
- Study completion
- Jul 2005
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the opportunity to take free supplemental hydromorphone (HYD) influences drug seeking behavior in heroin dependent individuals.
Detailed description
Drug dependence is a condition in which drug seeking holds a higher priority than behaviors controlled by other reinforcers. Learning to understand, predict, and control this maladaptive choice behavior may lead to improved prevention and treatment strategies. HYD is a drug 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 in heroin dependent individuals can be reduced by environmental factors, including supplemental opioid drug availability, drug price, and non-drug alternative reinforcers. Specifically, this study will determine whether pre-session opportunity to take "free" supplemental HYD influences HYD seeking by using a choice progressive ratio schedule as well as by varying the dose of HYD.
Participants in this observational study will undergo multiple test sessions in which they will select between acquiring drug or money. Because participants may choose money on all 12 trials of test sessions as a way to avoid receiving an injection, a placebo injection will be given when money is chosen. Prior to each test session, participants will receive a sample of the drug dose. During each test session, participants will have 12 opportunities to select either drug (administered as HYD) or money. Prior to each individual choice trial, participants will receive supplemental HYD. Participants will use a computer to earn choices. Respiration rate, oxygen saturation, heart rate, and blood pressure will be monitored throughout choice trials. Pupil diameter will be measured with a digital camera. Participants will complete self-report questionnaires at different times during the study. Participants will be maintained on buprenorphine throughout the study, with a fixed 3-week detoxification after study completion.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Current opiate dependence, verified by the structured clinical interview for DSM-IV (SCID) and Addiction Severity Index (ASI)
- Positive urine test for opiates
- Agreement to use adequate contraception for the duration of the study
- Able to read and write English
Key exclusion criteria (9 listed)
- DSM-IV diagnosis of a psychiatric illness
- History of or current neurological disease, including structural brain abnormalities, seizures, infection, peripheral neuropathy, and head trauma
- History of cardiovascular disease, myocardial infarction, chest pain, edema, systolic blood pressure greater than 160 mm Hg or less than 95 mm Hg, or diastolic blood pressure greater than 95 mm Hg
- Pulmonary disease, including obstructive pulmonary disease, cor pulmonale, tuberculosis, and asthma
- Systemic diseases, such as endocrinopathies, liver or kidney failure, myxedema, hypothyroidism, Addison's disease, or autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydromorphone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Derived from this study: PubMed 25911999Woodcock 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.
- Derived from this study: PubMed 25630964Stoltman 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.
- Derived from this study: PubMed 22339949Greenwald 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Greenwald, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heroin Dependence and Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00218309, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.