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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA031022 | U.S. NIH Grant/Contract | View source |
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The funding period ended.
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Omeros Corporation | INDUSTRY |
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The goal of the proposed research is to improve the effectiveness of treatments for opioid and for nicotine dependence by testing a novel pharmacological strategy. Specifically, pioglitazone, a peroxisome proliferator-activated gamma receptor (PPARγ) agonist, will be used as an adjunct to agonist-based treatment.
Although treatments for opioid and for nicotine dependence exist, these medications are not universally effective as many patients are unable to stop using or relapse rapidly, suggesting that treatment with a single agent alone is insufficient to facilitate cessation of use in many patients. Targeting additional pathways that may contribute to the maintenance of drug-taking behaviors or relapse may be a more effective strategy to treat individuals resistant to first-line approaches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - Heroin | Placebo Comparator | Participants will be maintained on 0 mg of Pioglitazone (PIO) prior to sessions assessing the abuse liability of heroin. |
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| PIO low dose - Heroin | Experimental | Participants will be maintained on 15 mg of PIO prior to sessions assessing the abuse liability of heroin. |
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| PIO high dose - Heroin | Experimental | Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of heroin. |
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| Placebo - Nicotine | Placebo Comparator | Participants will be maintained on 0 mg of PIO prior to sessions assessing the abuse liability of nicotine. |
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| PIO Low Dose - Nicotine | Experimental | Participants will be maintained on 15 mg of PIO prior to sessions assessing the abuse liability of nicotine |
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| PIO High Dose - Nicotine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIO | Drug | 0, 15, and 45 mg per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drug's Break Point | Number of operant responses (mouse clicks) participants were willing to provide in order to receive the drug under investigation (heroin or nicotine). The Breakpoint is the point at which participants stopped responding for the drug, i.e., the total number of clicks they were willing to provide in order to receive the drug. | Following 2 weeks of Pioglitazone (PIO) maintenance. |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability. | Visual analog scale ratings of "Liking" reported by the participant will be the primary endpoint (0-100 mm, 0=Not at all, 100=Extremely). | Following 2 weeks of Pioglitazone (PIO) maintenance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra D. Comer, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33140460 | Derived | Martinez S, Jones JD, Vadhan NP, Brandt L, Comer SD, Bisaga A. The acute and repeated effects of cigarette smoking and smoking-related cues on impulsivity. Drug Alcohol Rev. 2021 Jul;40(5):864-868. doi: 10.1111/dar.13206. Epub 2020 Nov 2. |
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Data will be presented at conferences and published in a peer-reviewed journal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo - Heroin | Control condition for active arms. Placebo: Placebo - Heroin |
| FG001 | Pio Low Dose - Heroin | Low dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day. |
| FG002 | Pio High Dose - Heroin | High dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day. |
| FG003 | Placebo - Nicotine | Control condition for active arms. Pioglitazone: 0, 15, and 45 mg per day. |
| FG004 | Pio Low Dose - Nicotine | Low dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day. |
| FG005 | Pio High Dose - Nicotine | High dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo - Heroin | Control condition for active arms. Placebo: Placebo - Heroin |
| BG001 | Pio Low Dose - Heroin | Low dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Drug's Break Point | Number of operant responses (mouse clicks) participants were willing to provide in order to receive the drug under investigation (heroin or nicotine). The Breakpoint is the point at which participants stopped responding for the drug, i.e., the total number of clicks they were willing to provide in order to receive the drug. | Posted | Mean | Standard Deviation | Mouse clicks | Following 2 weeks of Pioglitazone (PIO) maintenance. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo - Heroin | Control condition for active arms. Placebo: Placebo - Heroin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandra Comer PhD | New York State Psychiatric Institute | 646 774-6146 | sdc10@columbia.edu |
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| ID | Term |
|---|---|
| D006556 | Heroin Dependence |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of nicotine |
|
|
| Placebo | Drug | Placebo |
|
|
| BG002 | Pio High Dose - Heroin | High dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day. |
| BG003 | Placebo - Nicotine | Control condition for active arms. Pioglitazone: 0, 15, and 45 mg per day. |
| BG004 | Pio Low Dose - Nicotine | Low dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day. |
| BG005 | Pio High Dose - Nicotine | High dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Pio High Dose - Heroin |
High dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day. |
| OG003 | Placebo - Nicotine | Control condition for active arms. Pioglitazone: 0, 15, and 45 mg per day. |
| OG004 | Pio Low Dose- Nicotine | Low dose Pio comparator. |
| OG005 | Pio High Dose - Nicotine | High dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day. |
|
|
| Secondary | Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability. | Visual analog scale ratings of "Liking" reported by the participant will be the primary endpoint (0-100 mm, 0=Not at all, 100=Extremely). | Posted | Mean | Standard Error | units on a scale | Following 2 weeks of Pioglitazone (PIO) maintenance. |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Pio Low Dose - Heroin | Low dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day. | 0 | 4 | 0 | 4 |
| EG002 | Pio High Dose - Heroin | High dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day. | 0 | 18 | 0 | 18 |
| EG003 | Placebo - Nicotine | Control condition for active arms. Pioglitazone: 0, 15, and 45 mg per day. | 0 | 15 | 0 | 15 |
| EG004 | Pio Low Dose - Nicotine | Low dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day. | 0 | 9 | 0 | 9 |
| EG005 | Pio High Dose - Nicotine | High dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day. | 0 | 17 | 0 | 17 |
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| D001523 | Mental Disorders |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |