Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429767
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2007-01-30
Brief Title:
Sustained Release d-Amphetamine Buprenorphine on Drug Seeking Behavior in Opioid Cocaine Dependent Individuals
Sponsor:
Wayne State University
Organization:
Wayne State University
Study Overview
Official Title:
Reducing CocaineHeroin Abuse With SR-Amphetamine and Buprenorphine Study 1
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether maintenance on different oral doses of sustained release d-amphetamine SR-AMP combined with constant-dose sublingual buprenorphine BUP is safe and well tolerated and decreases self-administration of cocaine alone or combined with hydromorphone HYD Secondary aims are to determine whether SR-AMP attenuates the subjective and physiological effects of cocaine during drug sampling periods prior to choice opportunities
Detailed Description:
Heroin abusers also frequently abuse cocaine and concurrent use of these drugs is associated with more severe drug dependence and associated psychiatric and medical problems greater risk for HIV infection worse drug abuse treatment outcome and creates a public health burden New methods and solutions are needed for this problem
While human laboratory models exist to study choice of cocaine or opioids individually studies have not examined choice of cocaine alone or cocaineopioid combinations by heroin dependent individuals nor have there been interventions to reduce such drug use We recently developed a sensitive laboratory-based choice progressive ratio procedure to study drug-seeking behavior for opioids This study will extend this procedure in the form of drug combination vs money choices to obtain a novel human laboratory model of cocaineopioid abuse The purpose of this study is to determine whether maintenance on different doses of sustained release d-amphetamine SR-AMP combined with constant-dose buprenorphine BUP is safe and well tolerated and decreases self-administration of cocaine alone or combined with HYD Secondary aims are to determine whether SR-AMP attenuates the subjective and physiological effects of cocaine during drug sampling periods prior to choice opportunities
One goal of this new study is to develop a human laboratory model of polydrug abuse by allowing participants who abuse both heroin and cocaine to choose between drug combinations or money The second goal of this study is to develop medication treatments to reduce cocaine use by opioid dependent individuals
Participants in this observational study will take part in multiple trials in which they have the opportunity to choose between drug combinations cocaine alone or combined with HYD relative to HYD alone and dual placebo or money On the morning of each session prior to the choice procedure participants will receive a sample of the drug dose that can be chosen Participants will be asked to attend to the effects produced by the drug combination because they will be able to choose this relative to money in the choice task in the afternoon session During the choice procedure 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 the study Self-report questionnaires will be completed at different times during the study Participants will be maintained on a constant dose of BUP throughout the study with a minimum 2-week lead before the experiment and a fixed 3-week detoxification after study completion During the experiment they will be maintained on different doses of SR-AMP and on a constant dose of BUP
While human laboratory models exist to study choice of cocaine or opioids individually studies have not examined choice of cocaine alone or cocaineopioid combinations by heroin dependent individuals nor have there been interventions to reduce such drug use We recently developed a sensitive laboratory-based choice progressive ratio procedure to study drug-seeking behavior for opioids This study will extend this procedure in the form of drug combination vs money choices to obtain a novel human laboratory model of cocaineopioid abuse The purpose of this study is to determine whether maintenance on different doses of sustained release d-amphetamine SR-AMP combined with constant-dose buprenorphine BUP is safe and well tolerated and decreases self-administration of cocaine alone or combined with HYD Secondary aims are to determine whether SR-AMP attenuates the subjective and physiological effects of cocaine during drug sampling periods prior to choice opportunities
One goal of this new study is to develop a human laboratory model of polydrug abuse by allowing participants who abuse both heroin and cocaine to choose between drug combinations or money The second goal of this study is to develop medication treatments to reduce cocaine use by opioid dependent individuals
Participants in this observational study will take part in multiple trials in which they have the opportunity to choose between drug combinations cocaine alone or combined with HYD relative to HYD alone and dual placebo or money On the morning of each session prior to the choice procedure participants will receive a sample of the drug dose that can be chosen Participants will be asked to attend to the effects produced by the drug combination because they will be able to choose this relative to money in the choice task in the afternoon session During the choice procedure 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 the study Self-report questionnaires will be completed at different times during the study Participants will be maintained on a constant dose of BUP throughout the study with a minimum 2-week lead before the experiment and a fixed 3-week detoxification after study completion During the experiment they will be maintained on different doses of SR-AMP and on a constant dose of BUP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMCDA | OTHER | NIDA | httpsreporternihgovquickSearchR01DA022243 |
| R01DA022243 | NIH | None | None |