A Phase 3 interventional study of Intranasal challenge drug in Heroin Dependence, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-08.
Sponsored by New York State Psychiatric Institute · Phase 3, Interventional, and Basic science
The study is designed to compare the abuse liabilities of intranasal buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine. The investigators hypothesize that the abuse liability of buprenorphine/naloxone is lower than that of buprenorphine alone.
Although sublingual buprenorphine is an effective treatment for opioid addiction, the medication itself has abuse liability and, in some countries, has largely replaced heroin as the opioid drug of choice. In response to the reports of diversion and abuse of sublingual (SL) buprenorphine, a potentially less abusable formulation of buprenorphine that contains naloxone is being marketed in several countries. However, the relative abuse liability of buprenorphine alone and the buprenorphine/naloxone combination in buprenorphine-dependent individuals is unclear. Preliminary data from a study funded by Schering-Plough Corporation suggest that the buprenorphine/naloxone combination, when given intravenously (IV), does indeed have less abuse liability than IV buprenorphine in buprenorphine-dependent individuals. In addition to IV abuse of buprenorphine, epidemiological data suggest that buprenorphine is widely abused by the intranasal (IN) route. However, no data exist on the abuse liability of either IN buprenorphine alone or the buprenorphine/naloxone combination. Several studies have shown that naloxone is an effective antagonist of opioid agonist effects when given intravenously, but it is not clear whether naloxone given intranasally is as effective as when it is given by other routes of administration. Some studies have suggested that they are equally effective (Loimer et al., 1994), but others have shown that naloxone given intranasally is less effective (i.e., has a slower onset of effects) than when given by other routes of administration (Kelly et al., 2005). How this may impact on the ability of naloxone to reduce the reinforcing effects of IN buprenorphine is unclear. The primary aim of the current study proposal is to compare the reinforcing effects of IN buprenorphine and buprenorphine/naloxone in IN opioid abusers who are maintained on SL buprenorphine using a study design parallel to that used in our recent studies of the abuse liability of IV buprenorphine and buprenorphine/naloxone. Placebo, heroin, and naloxone will be used as neutral, positive, and negative controls, respectively. Secondary aims are to compare the subjective, performance, and physiological effects of IN buprenorphine and buprenorphine/naloxone. Overall, this study will complement our investigations of IV buprenorphine products by allowing for a complete overview within the same laboratory self-administration model of both the intravenous and intranasal abuse liability of buprenorphine versus buprenorphine/naloxone in individuals maintained on buprenorphine. The primary aim of the study is to compare the reinforcing effects of IN buprenorphine and IN buprenorphine/naloxone in opioid abusers maintained on different doses of sublingual buprenorphine. Secondary aims of the study are to compare the subjective, performance and physiological effects of IN buprenorphine and IN buprenorphine/naloxone. IN-administered placebo (lactose powder), naloxone alone, and heroin alone will be tested as neutral, negative, and positive control conditions, respectively. Participants (N=12 completers) will reside on an inpatient unit (5-South) during a 7 to 8-week study. This research will provide useful information to clinicians treating opioid dependent individuals with buprenorphine, and importantly, will provide information about the abuse potential and effects of buprenorphine on multiple measures of human functioning.
90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.
This study's enrollment of 27 is below the median of 87 across 57 interventional studies indexed under Heroin Dependence.
Browse Heroin Dependence studies →New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally.
Drug: Intranasal challenge drug
Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally.
Drug: Intranasal challenge drug
Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 2 mg of Naloxone.
Drug: Intranasal challenge drug
Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 8 mg of Naloxone.
Drug: Intranasal challenge drug
Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 16 mg of Naloxone.
Drug: Intranasal challenge drug
Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally with 4 mg of Naloxone.
Drug: Intranasal challenge drug
Intranasal challenge drug: 24 mg of heroin administered intranasally.
Drug: Intranasal challenge drug
Intranasal challenge drug: Intranasal lactose powder.
Drug: Intranasal challenge drug
Intranasal challenge drug: Intranasal Naloxone 4mg.
Drug: Intranasal challenge drug
Each of the experimental challenge drugs were administered intranasally to all participants in random order.
Drug Self-administration
The maximum number of responses (clicks on a computer mouse) the participant was willing to perform in order to receive a dose of the intranasal challenge drug under investigation.
Time frame: Throughout the testing sessions (approximately 9 weeks).
SOWS
Subjective opioid withdrawal scale (SOWS) measure (0-64). Greater score indicates more severe withdrawal.
Time frame: Throughout the testing sessions (approximately 9 weeks).
| Milestone | Intranasal Challege Drug |
|---|---|
| Started | 27 |
| Completed | 12 |
| Not completed | 15 |
The maximum number of responses (clicks on a computer mouse) the participant was willing to perform in order to receive a dose of the intranasal challenge drug under investigation.
| Clicks on a computer mouse | Bup 8 | Bup 16 | Bup/Nal 8/2 | Bup/Nal 8/8 | Bup/Nal 8/16 | Bup/Nal 16/4 | Heroin | Placebo | Naloxone 4 mg |
|---|---|---|---|---|---|---|---|---|---|
| Drug Self-administration | 350 ± 135 | 255 ± 121 | 223 ± 113 | 113 ± 83 | 2.7 ± 2.7 | 191 ± 112 | 755 ± 156 | 38 ± 23 | 45 ± 30 |
Subjective opioid withdrawal scale (SOWS) measure (0-64). Greater score indicates more severe withdrawal.
| units on a scale | Bup 8 | Bup 16 | Bup/Nal 8/2 | Bup/Nal 8/8 | Bup/Nal 8/16 | Bup/Nal 16/4 | Heroin | Placebo | Naloxone 4 mg |
|---|---|---|---|---|---|---|---|---|---|
| SOWS | 3 ± .5 | 3 ± .7 | 3 ± .9 | 3 ± .8 | 5 ± 1 | 3 ± .5 | 2 ± .3 | 2 ± .53 | 7 ± 1 |
Collected over Adverse events were collected from the day of admission until discharge and at 3 month follow-up. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intranasal Challege Drug | — | 0/27 (0%) | 2/27 (7.4%) |
| Event | Intranasal Challege Drug |
|---|---|
| Elevated liver function test (AST/ALT)Metabolism and nutrition disorders | 2/27 |
| Age, Continuous(years) | Intranasal Challege Drug |
|---|---|
| Mean | 39.3 ± 7.7 |
| Sex: Female, Male(Participants) | Intranasal Challege Drug |
|---|---|
| Female | 1 |
| Male | 26 |
| Race (NIH/OMB)(Participants) | Intranasal Challege Drug |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 10 |
| White | 10 |
| More than one race | 3 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Intranasal Challege Drug |
|---|---|
| United States | 27 |
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of May 2009, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2017, 2 years 9 months after primary completion.
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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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