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| ID | Type | Description | Link |
|---|---|---|---|
| NIDA 1U19DA10946 |
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Clinical data demonstrate that a cocaine vaccine (TA-CD: Celtic Pharmaceutical) produces selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct effects is unknown. The objective of this human laboratory study was to measure the relationship between antibody titers and the effects of smoked cocaine on ratings of intoxication, craving and cardiovascular effects.
Cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and at weekly intervals thereafter. Vaccinations occur at weeks 1, 3, 5 and 9.
I do not desire to provide a more extensive description.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose Vaccine | Experimental | All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 82ul |
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| High Dose Vaccine | Experimental | All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 360ul |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cocaine vaccine (TA-CD) | Biological | TA-CD (82,360 μg; IM) were administered at weeks 1, 3, 5 and 9. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cocaine Intoxication | Visual Analogue Scale ratings (0-100mm) of the Good Drug Effect cluster ("Good Drug Effect," "High," "Stimulated") over 13 weeks as a function of cocaine dose (25mg or 50mg). Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate more agreement with the statements. | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cocaine Cardiovascular Effects | Heart rate levels in Week 3 and Week 13 as a function of cocaine dose in High and Low antibody groups. Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate higher heart rates. | 13 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Haney, Ph.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York-Presbyterian Hospital | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19846066 | Derived | Haney M, Gunderson EW, Jiang H, Collins ED, Foltin RW. Cocaine-specific antibodies blunt the subjective effects of smoked cocaine in humans. Biol Psychiatry. 2010 Jan 1;67(1):59-65. doi: 10.1016/j.biopsych.2009.08.031. |
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Cocaine-dependent research volunteers who were explicitly not interested in treatment for their cocaine use signed a consent form approved by NYSPI IRB, which described the procedures and outlined the possible risks, including administration of an experimental vaccine and smoked cocaine.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Vaccine | All participants were vaccinated four times: in week 1, 3, 5, and 9. Cocaine vaccine (TA-CD): TA-CD (82 μg; IM) were administered at weeks 1, 3, 5 and 9. |
| FG001 | High Dose Vaccine | All participants were vaccinated four times: in week 1, 3, 5, and 9. Cocaine vaccine (TA-CD): TA-CD (360 μg; IM) were administered at weeks 1, 3, 5 and 9. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Overall, 10 volunteers participated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Vaccine (82μg) | All participants were vaccinated four times: in week 1, 3, 5, and 9. Cocaine vaccine (TA-CD): TA-CD (82 μg; IM) were administered at weeks 1, 3, 5 and 9. |
| BG001 | High Dose Vaccine (360μg) |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Cocaine Intoxication | Visual Analogue Scale ratings (0-100mm) of the Good Drug Effect cluster ("Good Drug Effect," "High," "Stimulated") over 13 weeks as a function of cocaine dose (25mg or 50mg). Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate more agreement with the statements. | Peak plasma antibody levels were highly variable. Thus, participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups for analysis, based on their peak antibody levels at Week 13, rather than by the dose of vaccine received. | Posted | Mean | Standard Error | units on a scale | 13 weeks |
|
2 years
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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 | Low Dose Vaccine | Each of four participants was vaccinated four times: in week 1, 3, 5, and 9. Cocaine vaccine (TA-CD): TA-CD (82 μg; IM) were administered at weeks 1, 3, 5 and 9. |
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There was no placebo TA-CD condition, due to the substantial study demands.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Haney, Ph.D. | New York State Psychiatric Institute at Columbia University Medical Center | 6467746153 | meg.haney@nyspi.columbia.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
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| Plasma Cocaine |
Plasma cocaine levels in Week 3 and Week 13 as a function of cocaine dose in High and Low AB groups. Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate higher plasma levels of cocaine. |
| 13 weeks |
| Protocol Violation |
|
All participants were vaccinated four times: in week 1, 3, 5, and 9.
Cocaine vaccine (TA-CD): TA-CD (360 μg; IM) were administered at weeks 1, 3, 5 and 9.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Week 3 Low Antibody | Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13. |
| OG002 | Week 5 Low Antibody | Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13. |
| OG003 | Week 7 Low Antibody | Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13. |
| OG004 | Week 9 Low Antibody | Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13. |
| OG005 | Week 11 Low Antibody | Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13. |
| OG006 | Week 13 Low Antibody | Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13. |
| OG007 | Week 1 High Antibody | Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13. |
| OG008 | Week 3 High Antibody | Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13. |
| OG009 | Week 5 High Antibody | Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13. |
| OG010 | Week 7 High Antibody | Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13. |
| OG011 | Week 9 High Antibody | Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13. |
| OG012 | Week 11 High Antibody | Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13. |
| OG013 | Week 13 High Antibody | Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13. |
|
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| Secondary | Cocaine Cardiovascular Effects | Heart rate levels in Week 3 and Week 13 as a function of cocaine dose in High and Low antibody groups. Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate higher heart rates. | Peak plasma antibody levels were highly variable. Thus, participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups for analysis, based on their peak antibody levels at Week 13, rather than by the dose of vaccine received. | Posted | Mean | Standard Error | BPM | 13 weeks |
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| Secondary | Plasma Cocaine | Plasma cocaine levels in Week 3 and Week 13 as a function of cocaine dose in High and Low AB groups. Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate higher plasma levels of cocaine. | Peak plasma antibody levels were highly variable. Thus, participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups for analysis, based on their peak antibody levels at Week 13, rather than by the dose of vaccine received. | Posted | Mean | Standard Error | ng/mL | 13 weeks |
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| 4 |
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| EG001 | High Dose Vaccine | Each of six participants was vaccinated four times: in week 1, 3, 5, and 9. Cocaine vaccine (TA-CD): TA-CD (360 μg; IM) were administered at weeks 1, 3, 5 and 9. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| Week 13 |
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| Week 13 |
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