Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01760473 | Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone | PHASE3 | COMPLETED | 27 | — | — | May 1, 2009 | Dec 1, 2014 | Sep 8, 2017 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Bup 8 | EXPERIMENTAL | Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally. |
| Bup 16 | EXPERIMENTAL | Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally. |
| Bup/Nal 8/2 | EXPERIMENTAL | Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 2 mg of Naloxone. |
| Bup/Nal 8/8 | EXPERIMENTAL | Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 8 mg of Naloxone. |
| Bup/Nal 8/16 | EXPERIMENTAL | Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 16 mg of Naloxone. |
| Bup/Nal 16/4 | EXPERIMENTAL | Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally with 4 mg of Naloxone. |
| Heroin | ACTIVE_COMPARATOR | Intranasal challenge drug: 24 mg of heroin administered intranasally. |
| Placebo | SHAM_COMPARATOR | Intranasal challenge drug: Intranasal lactose powder. |
| Naloxone 4 mg | ACTIVE_COMPARATOR | Intranasal challenge drug: Intranasal Naloxone 4mg. |
| Name | Type | Description |
|---|---|---|
| Intranasal challenge drug | DRUG | Each of the experimental challenge drugs were administered intranasally to all participants in random order. |
Inclusion Criteria: * DSM IV criteria for heroin dependence * No major mood, psychotic, or anxiety disorder * Physically healthy * Able to perform study procedures * 21-45 years of age * Normal body weight * Current use of opioids in amounts and/or frequencies that meet or exceed those used in the ...