Trial Outcomes & Findings for Therapeutic Cocaine Vaccine: Human Laboratory Study (NCT NCT00965263)
NCT ID: NCT00965263
Last Updated: 2017-12-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
13 weeks
Results posted on
2017-12-11
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Family emergency
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Therapeutic Cocaine Vaccine: Human Laboratory Study
Baseline characteristics by cohort
| Measure |
Low Dose Vaccine (82μg)
n=4 Participants
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.
|
High Dose Vaccine (360μg)
n=6 Participants
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.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
39 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
39 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 13 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Week 1 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 3 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 5 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 7 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 9 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 11 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 13 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 1 High Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 3 High Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 5 High Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 7 High Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 9 High Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 11 High Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 13 High Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cocaine Intoxication
Good Drug Effect of 25 mg cocaine
|
59 units on a scale
Standard Error 9
|
51 units on a scale
Standard Error 8
|
45 units on a scale
Standard Error 9
|
44 units on a scale
Standard Error 8
|
42 units on a scale
Standard Error 8
|
38 units on a scale
Standard Error 8
|
40 units on a scale
Standard Error 7
|
58 units on a scale
Standard Error 8
|
32 units on a scale
Standard Error 8
|
29 units on a scale
Standard Error 0
|
23 units on a scale
Standard Error 4
|
29 units on a scale
Standard Error 3
|
19 units on a scale
Standard Error 3
|
10 units on a scale
Standard Error 2
|
|
Cocaine Intoxication
Good Drug Effect of 50 mg cocaine
|
83 units on a scale
Standard Error 4
|
68 units on a scale
Standard Error 8
|
61 units on a scale
Standard Error 7
|
58 units on a scale
Standard Error 8
|
58 units on a scale
Standard Error 8
|
50 units on a scale
Standard Error 10
|
60 units on a scale
Standard Error 8
|
62 units on a scale
Standard Error 8
|
50 units on a scale
Standard Error 8
|
48 units on a scale
Standard Error 4
|
48 units on a scale
Standard Error 8
|
42 units on a scale
Standard Error 6
|
48 units on a scale
Standard Error 5
|
25 units on a scale
Standard Error 5
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Week 1 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 3 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 5 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 7 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 9 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 11 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 13 Low Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 1 High Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 3 High Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 5 High Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 7 High Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 9 High Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 11 High Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 13 High Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cocaine Cardiovascular Effects
Week 3
|
75 BPM
Standard Error 3
|
82 BPM
Standard Error 2
|
92 BPM
Standard Error 1
|
79 BPM
Standard Error 1.5
|
98 BPM
Standard Error 3
|
109 BPM
Standard Error 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cocaine Cardiovascular Effects
Week 13
|
76 BPM
Standard Error 2
|
99 BPM
Standard Error 2
|
102 BPM
Standard Error 2
|
82 BPM
Standard Error 2
|
101 BPM
Standard Error 5
|
122 BPM
Standard Error 6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Week 1 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 3 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 5 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 7 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 9 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 11 Low Antibody
n=5 Participants
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 13 Low Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 1 High Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 3 High Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 5 High Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 7 High Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 9 High Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 11 High Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
Week 13 High Antibody
Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Cocaine
Week 3
|
5 ng/mL
Standard Error 0.2
|
125 ng/mL
Standard Error 8
|
160 ng/mL
Standard Error 10
|
20 ng/mL
Standard Error 2
|
145 ng/mL
Standard Error 20
|
260 ng/mL
Standard Error 40
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Cocaine
Week 13
|
25 ng/mL
Standard Error 2
|
110 ng/mL
Standard Error 5
|
200 ng/mL
Standard Error 20
|
25 ng/mL
Standard Error 2
|
175 ng/mL
Standard Error 10
|
325 ng/mL
Standard Error 50
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Low Dose Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Dose Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Margaret Haney, Ph.D.
New York State Psychiatric Institute at Columbia University Medical Center
Phone: 6467746153
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place