Cocaine DependencePhase 2NCT00965263

Therapeutic Cocaine Vaccine: Human Laboratory Study

A Phase 2 study testing Cocaine vaccine (TA-CD) in people with Cocaine Dependence, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Cocaine Dependence
What is being tested?: Cocaine vaccine (TA-CD)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Mar 2003to Aug 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Meets DSM-IV criteria for current cocaine dependence. The volunteer may meet criteria for other substance abuse, but not dependence (other than nicotine).
Primary route of cocaine administration is smoking.
Age 21-45.
Females must be surgically sterilized or post- menopausal
Able to give informed consent, and comply with study procedures.

Who cannot join

Dependence on substances other than cocaine or nicotine.
Judged to be noncompliant with study protocol.
History of autoimmune disease, immune deficiency or hypersensitivity to other vaccines. An HIV test must be negative.
Currently uses drugs intravenously
Currently taking any psychotropic medication
Laboratory tests that are clinically unacceptable to the study physician (BP > 140/90; BUN, creatinine, LFTs > 1.5 ULN; hematocrit < 34 for women, < 36 for men)

Show all 10Show fewer

Blood or blood products given in the three months prior to vaccination
Other vaccines, including flu vaccine, given within 30 days of screening.
Ongoing active infection
Currently taking immunosuppressives -

Trial locations and contacts

1 site in 1 country.

United States1 site

New York-Presbyterian Hospital
New York, New York, 10032

Other trials in United States

About this study

Official title: Tests of a Therapeutic Cocaine Vaccine

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.

Read the detailed description

I do not desire to provide a more extensive description.

Conditions: Cocaine Dependence
Being tested: Cocaine vaccine (TA-CD)
Keywords: Cocaine, immunotherapy, vaccination, antibody, addiction, dependence
Medical subject headings: Cocaine-Related Disorders, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cocaine vaccine (TA-CD)Biological
TA-CD (82,360 μg; IM) were administered at weeks 1, 3, 5 and 9.

Study groups in NCT00965263
Study group	Role	What they receive
Low dose Vaccine	Experimental	All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 82ul Receives: Biological: Cocaine vaccine (TA-CD)
High Dose Vaccine	Experimental	All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 360ul Receives: Biological: Cocaine vaccine (TA-CD)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 13 weeks

Secondary outcomes (2)

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.
Measured: 13 weeks
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.
Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2003Aug 2009

First posted25 Aug 2009 (estimated)
Study startMar 2003
Primary completionJul 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cocaine DependenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00965263
Sponsor's protocol ID: #3980
Other IDs: NIDA 1U19DA10946
Status last verified: Sep 2017
First submitted: 24 Aug 2009
Last updated: 11 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 19846066

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tests of a Therapeutic Cocaine Vaccine
ClinicalTrials.gov ID: NCT00965263
Acronym / sponsor ID: #3980
Conditions: Cocaine Dependence
Keywords: Cocaine, immunotherapy, vaccination, antibody, addiction, dependence
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Study start: Mar 2003
Primary completion: Jul 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 25 Aug 2009 (estimated)
Results: Posted 11 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

I do not desire to provide a more extensive description.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Low dose Vaccine	Experimental	Biological: Cocaine vaccine (TA-CD)All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 82ul
High Dose Vaccine	Experimental	Biological: Cocaine vaccine (TA-CD)All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 360ul

Who may qualify

Ages: 21 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Meets DSM-IV criteria for current cocaine dependence. The volunteer may meet criteria for other substance abuse, but not dependence (other than nicotine).
Primary route of cocaine administration is smoking.
Age 21-45.
Females must be surgically sterilized or post- menopausal
Able to give informed consent, and comply with study procedures.

Key exclusion criteria (10 listed)

Dependence on substances other than cocaine or nicotine.
Judged to be noncompliant with study protocol.
History of autoimmune disease, immune deficiency or hypersensitivity to other vaccines. An HIV test must be negative.
Currently uses drugs intravenously
Currently taking any psychotropic medication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cocaine vaccine (TA-CD)TA-CD (82,360 μg; IM) were administered at weeks 1, 3, 5 and 9.	Biological	High Dose Vaccine, Low dose Vaccine

Primary outcome

Cocaine Intoxication
Time frame: 13 weeks
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.

2 secondary outcomes

Cocaine Cardiovascular Effects
Time frame: 13 weeks
Plasma Cocaine
Time frame: 13 weeks

Results and safety

Results posted to the registry on 11 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose Vaccine	6	4
High Dose Vaccine	9	6

Primary outcome: Cocaine Intoxication

Time frame: 13 weeks. Mean (Standard Error). Unit: units on a scale

Measure	Week 1 Low Antibody n = 5	Week 3 Low Antibody n = 5	Week 5 Low Antibody n = 5	Week 7 Low Antibody n = 5	Week 9 Low Antibody n = 5	Week 11 Low Antibody n = 5	Week 13 Low Antibody n = 5	Week 1 High Antibody n = 5	Week 3 High Antibody n = 5	Week 5 High Antibody n = 5	Week 7 High Antibody n = 5	Week 9 High Antibody n = 5	Week 11 High Antibody n = 5	Week 13 High Antibody n = 5
Good Drug Effect of 25 mg cocaine	59 (9)	51 (8)	45 (9)	44 (8)	42 (8)	38 (8)	40 (7)	58 (8)	32 (8)	29 (0)	23 (4)	29 (3)	19 (3)	10 (2)
Good Drug Effect of 50 mg cocaine	83 (4)	68 (8)	61 (7)	58 (8)	58 (8)	50 (10)	60 (8)	62 (8)	50 (8)	48 (4)	48 (8)	42 (6)	48 (5)	25 (5)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose Vaccine	0 of 4 (0%)	0 of 4 (0%)	0 of 4
High Dose Vaccine	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): There was no placebo TA-CD condition, due to the substantial study demands.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19846066Haney 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Margaret Haney, Ph.D. principal investigator

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cocaine vaccine (TA-CD) in people with Cocaine Dependence, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cocaine Intoxication (time frame: 13 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00965263, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.