P r o g e t t o START COCAINA VERONA CONGRESS 2006 A preliminary feasibility study for the trial of anti-cocaine vaccine Bertoncelli Sara R egionale sulle D ipendenze sservatorio O D ipendenze sservatorio O P r o g e t t o START COCAINA COCAINA VERONA WORKSHOP 2006
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P r o g e t t o
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A preliminary feasibilitystudy for the trial of anti-cocaine vaccine
Bertoncelli Sara
R egionale sulleD ipendenze
sservatorio O D ipendenze
sservatorio O
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2006 Index
- Aim of the study- Target- Methodology- Results
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2006 General aim of the study
Preliminary processing of the data collectedthrough self-administrated questionnairesaimed at investigating:
1. acceptability2. reasons3. doubts
about anti-cocaine vaccine trial.
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Specific objectives
1. Investigate the perception of efficacy of the anti-cocaine vaccine by professionals and cocaine users
2. Investigate trial acceptability3. Investigate reasons and doubts about joining
the trial4. Evaluate the warranties that both the targets
consider necessary in order to join the trial5. Identify the information that professionals and
cocaine users think are necessary beforejoining the trial
6. Compare the opinions of the two targets aboutsame areas of investigation
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Target
1. Drug abuse professionals:
PhysicianPsychologistPsychiatristNurseSocial workerEducatorResearcherSociologist
2. Cocaine users
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Methodology
Self-administration of questionnaires at thetwo target populations (drug abuseprofessionals and cocaine users) afferent thefollowing services in Italy:
1. Drug abuse services2. Therapeutical communities3. Social cooperatives4. Narcotics Anonymus (Self-help Association)
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Enti coinvolti
ASL N. 1 Benevento - U.O.S. Dipendenze patologiche Telese TermeAS N. 4 – U.O.C. SerT CosenzaASL NA 4 - U.O. Complessa SerT di Nola distretto 73ASL N. 5 - SerT di Rivoli - Dipartimento Patologia delle Dipendenze Collegno TOASL N. 5 - Comunità Terapeutica Lucignolo & Co RivoliAS N. 7 – SerT CatanzaroAUSL N. 8 Dipartimento delle Dipendenze di SiracusaAST N. 11 – Dipartimento delle Dipendenze Reggio CalabriaULSS N. 20 Dipartimento delle Dipendenze di Verona (SerT1; SerT2; SerT3)ASL Bergamo – SerT Bergamo 2 MartinengoASL Brescia – SerT BresciaASL Como – Sert Appiano GentileASL Cremona – SerD CremaAUSL FG2 - SerT di Cerignola – Dipartimento Dipendenze PatologicheUSL Modena - SerT di Mirandola (Dipartimento di Salute Mentale - Settore
Dipendenze Patologiche)AUSL Parma – SerT di ParmaASL Varese - Dipartimento delle DipendenzeASUR zona 3 – SerT di CampobassoNarcotici Anonimi - Associazione di auto-mutuo aiuto
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Areas of the questionnaire
1. Perception of efficacy of the anti-cocaine vaccine2. Importance assigned to psychological support3. Importance assigned to privacy and anonymity4. Perceived risk of the tempation of overcoming the anti-
cocaine vaccine barrier5. Perceived efficacy of a possible preventive vaccine6. Perceived problems of the controls respect7. Perception of a possible social discrimination (having to go
to the drug abuse service, positivity to anti-cocaineantibodies)
8. Acceptability of the trial 9. Reasons in favour of joining the trial10.Doubts about joining the trial11. Perception of efficacy of pharmacological therapies in the
treatment of drug abuse12.Warrenties necessary to take part in the trial13.Necessity of more information on anti-cocaine vaccine
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Results: subjects interviewed
A total number of 344 subjects repliedto the questionnaires, amongst whom:
170 drug abuse professionals174 cocaine users
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Cocaine users’ features
Cocaine consumers are mainly male (89,1%) and the mean age of the groupis 33 years. The mean age of the first use of cocaine is 18 years.
Gender distribution (%)
89,1
9,8 1,1
male female no answer
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Education (%)
Employment (%)
Marital status (%)
Cocaine users’ features
5,7
49,434
5,7 5,2
primary school secondary schoolhigh school universitytraining school
60,4
23
10,94,6
1,10
10
20
30
40
50
60
70
single married separate divorced no answer
1,1 4
61,5
30,5
2,9
no answer student empolyed unemployed retired
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Current cocaine use (%)
At present Cocaine consumers mainly don’t use cocaine or use itoccasionally (75,3%)
Cocaine users’ features
37,9 37,4
23,6
1,10
5
10
15
20
25
30
35
40
no use occasional continuous no answer
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Amongst cocaine consumers currently using cocaine, 50% refer snort as mainway of taking it. To be pointed out that in these percentages are countedpeople using more than one way of taking, too.
Current way of cocaine taking (%)
Cocaine users’ features
0,6
1,7
20,7
26,4
27
50
0 10 20 30 40 50 60
Intramuscolar
Oral
Inhalation
Intravenus
Smoked
Snorted
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26,4% of cocaine consumers refer having not use cocaine in the last 30 days
Frequency of cocaine use in the last 30 days (%)
Cocaine users’ features
24,7
9,2
19
9,2 10,9
0,6
26,4
0
10
20
30
no use 1-3 monthl y 1 weekl y mor e t i mes a
week
dai l y mor e t i mes a day no answer
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Use of other substances in the last 30 days (%)
The more frequently substances used in the last 30 days are cannabis (29,9%) and alcohol (24,2%). To be noted that in these percentages are counted people usingmore than one substance, too. 29,9% of the sample refers not having used othersubstances.
Cocaine users’ features
1,7
2,3
2,3
2,9
2,9
20,7
21,8
24,2
29,9
0 5 10 15 20 25 30 35
mushrooms
ecstasy
amphetamine
buprenorphine
benzodiazepine
methadone
heroine
alcohol
cannabis
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Treatments in the past 12 months (%)
Treatments in the past (%)
Cocaine users’ features
58
39,1
2,9
yes no no answer
37,9
9,25,2 4,66,3
36,8
0
5
10
1520
25
30
35
40
one none more thanthree
two no answer three
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Type of treatment in the last 12 months (%)
Cocaine users’ features
1,7
10,3
14,9
25,9
32,8
8,6
0 5 10 15 20 25 30 35
No answer
Other
Sel f -help
Phar maco/ psycho
Psychological
Phar macological
The therapy most frequently referred in the last year is the pharmacologicaltreatment (32,8%), followed by the psychological one (25,9%). People whohave referred more than one treatment are also included in the calculationof the percentages. 36,8% have not been submitted to treatment in the previous 12 months.
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Professionals’ features
Gender distribution (%)
Professionals’ mean age is 45 years
Marital Status (%)
Working agency (%)
35,3
64,1
0,6
male female no answer
71,2
15,9
5,9 2,9 2,91,2
married single separate
divorced no answ er w idow ed
94,1
4,7 0,6 0,60
20
40
60
80
100
sert rehabilitationcentre
socialcooperative
no answerr
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Profession (%)
Years of Operativeness (%)
1,8
2,2
2,4
4,7
12,4
13,5
15,9
22,4
24,7
0 5 10 15 20 25 30
psychiatrist
no answer
researcher
sociologist
educator
social worker
psychologist
nurse
physician
2,3
5,3
12,4
12,9
17,1
23,5
26,5
0 5 10 15 20 25 30
no answer
less than 1 ys
more than 20 ys
from 1 to 5 ys
from 16 to 20 ys
from 6 to 10 ys
from 11 to 16 ys
Professionals’ features
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2006 Perception of efficacy (%)
According to most consumers and professionals (59,8% and 87% respectively) the anti-cocaine vaccine for the cocaine addiction treatment can be useful only if associated with psychological support.
1,8 0,6 3,514,4
5,2 2,9
17,76,5
87,6
59,8
0
20
40
60
80
100
Useful alone too Useful only withpsychological
support
Irrelevant anyway Demaging Hesitating
Professionals Users
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2006 Perception of vaccine benefit (1)
Overcoming drug-abuse (%)
37,154,662,9
45,4
0
20
40
60
80
100
yes no
Professionals Users Reducing craving (%)
62,437,6
54,645,4
020406080
100
yes no
Professionals Users
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17,27,1
92,982,8
0
2040
6080
100
yes noProfessionals Users
Preventing relapse (%)
Preventing overdose (%)
55,3 44,732,8
67,2
020406080
100
yes noProfessionals Users
The question included the possibility to provide more replies on the vaccine utility. 3,5% of professionals and 12,6% of users replied “I don’t know”.
Perception of vaccine benefit (2)
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21,2
4,1 0,6 1,2
64,4
20,1
5,20,6
9,7
72,9
0
20
40
60
80
Alwaysassociat ed
can beassociat ed
no necessary not t o beassociat ed
Hesit at ing
professionals Users
Association of the vaccine with psychological support (%)
Users and professionals confirm the necessity to associate the vaccine withpsychological support in order to make it effective.
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82,9
6,5
77,6
810,6 14,4
0
20
40
60
80
100
yes no Hesitating
Professionals Users
Necessity of complete anonymity (%)
According to users and professionals it is necessary to guarantee the anonymity during the trial.
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64,7
25,3
64,4
20,1 15,510
0
20
40
60
80
100
yes no hesitating
Professionals Users
Risk of overcomingthe vaccine barrier (%)
According to most users and professionals, many would try to overcome the barrier of the blocking effect of the vaccine by taking higher doses of cocaine.
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Perception of the efficacy of a possiblepreventive vaccine (%)
24,7
50
25,3
37,440,8
21,8
0
10
20
30
40
50
60
yes no hesitating
Professionals Users
The majority of both the groups think that vaccinating people at risk whohave never used cocaine is ineffective in order to avoid the use in the future. Yet, it must be pointed out that a high percentage is not sure and that users are in favour of the preventive vaccine (37,4%).
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24,7
50
25,3
37,440,8
21,8
0
20
40
60
80
yes no hesitat ing
Professionals Users
Controls too demanding? (%)
Both the groups think that being submitted to weekly periodical controlsduring the trial isn’t too demanding for the patients.
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40,6
58,8
0,6
46,6 45,4
8
0
20
40
60
80
100
yes no hesitating
Professionals Users
60,6
35,9
3,5
27
62,1
10,9
0
20
40
60
80
100
yes no hesitating
Professionals Users
Possible risk of social discrimination (%)
Fear of discriminationas obstacle to partecipation (%)
Risk of social discrimination? (%)
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Anti-cocaine antibodies positivityas a problem? (%)
37,6
8,3
55,8
14,9
54,1
29,3
0
20
40
60
80
100
yes no hesitatingProfessionals Users
55,3
3843,6
18,4
31,8
12,9
0
20
40
60
80
100
yes no hesitating
Professionals Users
Anti-cocaine antibodies positivity as a problem (%)
Anti-cocaine antibodies positivity as obstacleto partecipation (%)
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76,4
8,315,3
57,5
23 19,5
0
20
40
60
80
100
yes no hesitating
Professionals Users
Acceptability of the trial (%)
76,4% of the professionals would suggest to a close person the partecipationin the cocaine vaccine trials. 57,5% of the users would be willing to beenrolled. To be pointed out the high percentage of hesitation amongst users(19,5%).
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0,8
1,5
1,5
2,7
3,8
4,6
5,4
6,9
7,7
9,2
15,4
19,9
26,1
27,7
38,5
0 5 10 15 20 25 30 35 40 45
It's not def ini tive
A good motivation
Anonymity
None
Scienti f ic data on ef f icacy
Fai lure of pr evious tr eatment
Overcoming drug-abuse
Preventing r isks connected to cocaine use
Receiving also a psychological suppor t
Saf ety/ Toler abi l i ty of vaccine
Improving Quali ty of l i f e
No answer
Testing drug-f r ee state
It's the only pharmacological therapy
Blocking cocaine ef f ects
Reasons pro-trial by professionals (%)
Amongst professionals who have expressed a positive opinion towards trials, the three mostfrequent reasons are: the action of the vaccine which contrasts the effects of the cocaine, reinforcing the reason for not using it (38,5%); the fact that is the only therapy available forthe treatment of cocaine dependence and that could be effective; at last the possibility of reaching a drug free state. Each professional can have expressed more favourable reasons.
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2
2
3
5
6
9
10
10
12
13
19
43
0 5 10 15 20 25 30 35 40 45 50
None
No Answer
Saving money
Not having alternative
Preventing / reducing craving
Knowing not to perceive effects
Preventing risks connected to cocaine use
Having an help/feeling more sure
Testing its efficacy
Having the security not to relapse
Change life
Overcoming drug-abuse
Reasons pro-trial by consumers (%)
Amongst users who have expressed a positive opinion towards the trials, the mostfrequent reason is to be able to overcome drug dependence (43%), followed by the hopeto change life and recover the important relations (19%). Each user can have expressedmore reasons pro-trial.
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7,1
14,3
35,7
64,3
0 10 20 30 40 50 60 70
No answer
None
Risks for physical health
It's still a trial/uncertainty
Doubts of the professionals on the partecipation to trial (%)
Amongst professionals who have expressed a negative opinion towards the trial the most frequent doubt is the uncertainty of the experimental phase(64,3%), followed by the fear for the health risks (35,7%).
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2,5
2,5
5
7,5
7,5
10
10
10
10
12,5
17,5
17,5
17,5
0 2 4 6 8 10 12 14 16 18 20
Fear of overdose
All
Not sure about wanting to stop use
None
Risks for physical health
Fear about not stopping of complusion to use
No answer
Doubts about its efficacy
Temptation to overcome vaccine barrier
Wanting to use cocaine
Fear of social discrimination
I don't need vaccine
It's still a trial/uncertainty
Doubts of the consumers on the partecipation to trial (%)
Amongst users who have expressed a negative opinion towards the trial, the most frequentdoubts are (17,5%): the uncertainty associated with the trial phase; the perception of being able to manage without the vaccine and the fear of being discovered, discriminatedand of having legal problems for the positivity at anti-cocaine antibodies.
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59,4
26,5
1,8 2,47,6
2,4
59,8
8,6 7,52,3
20,1
1,7
0
10
20
30
40
50
60
70
Suggested Enoughsuggested
Not suggested Less suggested Hesitating No answer
Suggestion of pharmacological therapiesfor drug abuse
The use of pharmacological therapies is suggested for the treatment of drug abuse both by most of professionals (59,4%) and users (59,8%).
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Warrenties necessary to take part in the trialby professionals (mean value)
Level of importanceMin Max
3,3
3,5
3,8
3,9
3,9
4
4
4,2
4,4
1 1,5 2 2,5 3 3,5 4 4,5 5
Anonymity
Information about social effects
Insurance cover
Information about psychological effects
Efficacy
Privacy
Psychological care
Information about physical effects
Medical care
Professionals retain necessary warrenties to take part in the trial givingpatiences medical and psychological care and clear information about physicalhealth.
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AVERO
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3,7
3,7
4
4,1
4,3
4,3
4,5
4,6
4,7
1 1,5 2 2,5 3 3,5 4 4,5 5
Information about social effects
Anonymity
Privacy
Insurance cover
Efficacy
Psychological care
Medical care
Information about psychological effects
Information about physical effects
Min Max
Level of importance
Warrenties necessary to take part in the trialby users (mean value)
Users retain necessary warrenties to take part in the trial receiving clearinformation about physical and psychological health and having a medical and psychological care.
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Necessity of other information (%)
5045,9
4,1
41,4
56,9
1,70
10
20
30
40
50
60
Yes No No answer
Professionals Users
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0,6
0,6
0,6
1,2
1,8
1,8
2,9
2,9
3,5
10
12,4
37,1
0 5 10 15 20 25 30 35 40
Pr eventive vaccination
Avai labi l i ty of Ig anti-cocaine f or over dose
Over coming vaccine bar r ier
Atti tude of the Minister y of health
Use of other substance as an alter native to cocaine
Psychological ef f ects
N of possible administr ations/ r isks
Pr of essional tr aining
Vaccine inter actions with other dr ugs
Physical health r isks
Futur e tr ial pr otocol
Pr evious exper imentation data
Professionals: necessary information
Amongst the information that the professionals consider missing and necessary, at first place there are the scientific data on previous trials, followed by more details on future trial protocol and on the health risks.
P r o g e t t o
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AVERO
NA C
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GRESS 2
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CO
CA
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CO
CAIN
AVERO
NA W
ORKSH
OP
2006
2,9
4
4
5,2
5,7
16,1
19
19,5
0 5 10 15 20 25
Legal impl ication of anti-cocaineantibodies positive r esults
Over dose r isk
Psychological ef f ects
Par tecipation detai ls
Vaccine composition
Ef f icacy data
Closer detai ls
Physical ef f ects
Users think it is necessary to receive more information on health risks, a generaldeepening, more data on previous trials and on direct experiences of the vaccine efficacy.
Consumers: necessary information
P r o g e t t o
STARTC
OC
AIN
AVERO
NA C
ON
GRESS 2
006
CO
CA
INA
CO
CAIN
AVERO
NA W
ORKSH
OP
2006
Conclusions (1)
1. The acceptability of the anti-cocaine vaccine trial is high both byprofessionals and cocaine users. The three most frequent reasons pro-trial by professionals are: the action of the vaccine which contrasts the effects of the cocaine, reinforcing the reason for not using it; the factthat is the only therapy available for the treatment of cocainedependence and that could be effective; at last the possibility of reachinga drug free state. Amongst users who have expressed a positive opinion towards the trial, the most frequent reasons are: being able to overcomedrug dependence, followed by the hope to change life and recoverimportant relationships. Both refer as main reason fon not acceptabilityof the trial the uncertainty connected to the experimental phase of the vaccine;
2. The utility of the anti-cocaine vaccine is referred by both the tragets in reaching and maintining a drug-free state (overcoming dependence) and preventing relapse;
3. According to most consumers and professionals the anti-cocaine vaccine, for the cocaine addiction treatment, can be useful and effective only ifassociated with psychological support which remain indispensable;
P r o g e t t o
STARTC
OC
AIN
AVERO
NA C
ON
GRESS 2
006
CO
CA
INA
CO
CAIN
AVERO
NA W
ORKSH
OP
2006
Conclusions (2)
4. The questionnaire has also permitted to identify doubts and fears aboutthe trial, in order to give clearer and specific information in the future, making easier the process of decison making;
5. In detail, professionals and cocaine users think it is necessary to receivemore data on previous experimentations (efficacy, safety, tolerability, number of subjects involved, risk of overcoming the vaccine barrier, interactions with other drugs, use of other substances in alternative of cocaine, etc) and on the future trial protocol (admission criteria, duration, place of trial, etc);
6.6. FearFear of social of social discriminationdiscrimination by cocaine users is one of the main reasonfor the unacceptability of the trial (for example: going to a drug abuseservice for the administration of the vaccine; legal implications for the positivity at anti-cocaine antibodies), thus is to be considered with greatattention;
7. Finally, it is necessary to give a clear information about the anti-cocainevacccine mechanism of action, in order to improve its efficacy and toreduce unreal expectations on “magic” solution of the dependence onlythanks to having been vaccinated.
P r o g e t t o
STARTC
OC
AIN
AVERO
NA C
ON
GRESS 2
006
CO
CA
INA
CO
CAIN
AVERO
NA W
ORKSH
OP
2006
THANKS THANKS THANKS FOR YOUR ATTENTIONFOR YOUR ATTENTIONFOR YOUR ATTENTION
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