A Randomised Controlled Trial

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Debra Johns
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1 Efficacy of the KISS Programme: Self Control of Drug Consumption in Severely Dependent Drug Addicts: A Randomised Controlled Trial ICMI Conference 2012, Venice Gabi Becker (managing director, Integrative Drogenhilfe Ffm., IDH) Prof. Dr. Hans Volker Happel, (University of Applied Sciences, Ffm.) Prof. Dr. Joachim Körkel, (University of Applied Sciences, Nürnberg) Prof. Dr. Gero Lipsmeier, (University of Applied Sciences, Ffm.)

Drogenhilfe Ffm., IDH) Prof. Dr. Hans Volker Happel, (University of Applied Sciences, Ffm.) Prof. Dr. Joachim Körkel, (University of Applied Sciences, Nürnberg) Prof.

2 Overview IDH Frankfurt KISS Programme Research Questions Study Design Results

3 Integrative Drogenhilfe founded in 1986 in the City of Frankfurt/Germany runs 8 low treshold institutions Overnight accomodation for homeless drug addicts, flatsharing community, crisis centers, safe injection rooms, handicraft-workshops, vocational training facilities shelter and counselling for sex workers Consultancy and guidance for (HIV*+) children and their drug using parents 150 employees (social workers, craftsmen, psychologists, administrators, manager) different clients per year

vocational training facilities shelter and counselling for sex workers Consultancy and guidance for (HIV*+) children and

4 IDH-Institutions with KISS groups ( Study centers ) Niddastraße (Safe injection room in the red-light district) Eastside (Shelter, contact center, safe injection room, working programs, methadone maintenance treatment, psychosocial care) FriedA (Contact center with methadone maintenance treatment) Körkel, Becker, Happel & Lipsmeier (2008)

working programs, methadone maintenance treatment, psychosocial care) FriedA

6 Starting point 2005 All 150 employees were trained in Motivational Interviewing (social workers 7 days, the rest 4 days) We had 2 goals, when we started to have MI as a foundation of our work: Increase of competence and satisfaction of our employees Increase of the willingness for change in our clients The main question became: How to raise the motivation for change of the consumption behaviour of our clients Consequence: Search for suitable programmes Result: KISS Programme

of our employees Increase of the willingness for change in our clients The main question became: How to raise the

7 Definition: Self Controlled Consumption Self-controlled drug intake = a person is following a predetermined consumption plan set up by himself/ herself. This means to plan ahead for one week: the number of abstinent days the maximum number of standard consumption units (SCU) on a consumption day the maximum number of SCU in the whole week and to set other constraints (such as when, where, and with whom to consume)

This means to plan ahead for one week: the number of abstinent days the maximum number of standard

8 Characteristics of KISS created by Prof. Dr. Joachim Körkel Group programme (max. 12 participants), also available as individual programme, 1-2 skilled KISS-trainers Goal: Reducing the use of legal / illegal drugs. Abstinence is of course also possible! In the strict sense of MI: Client decides, which drugs to reduce and how quick it will be changed. Structure of behavioral therapy (BSCT), ca. 3,5 months: 1-2 preliminary talks 12 structured weekly modules (à 2¼ hrs.) Contents

illegal drugs. Abstinence is of course also possible!

9 Content of the 12 KISS Modules 1. Basic knowledge of drugs 2. Pros & cons for change 3. Consumption balance 4. Initial definition of individual goals 5. Strategies for reaching the goal (control) 6. Dealing with risky situations 7. Handling episodes 8. Leisure activities 9. Identifying strains 10. Dealing with strains 11. Social competences ( Say-no ) 12. Saving success ( How to go on? )

Strategies for reaching the goal (control) 6. Dealing with risky situations 7.

10 Consumption Diary (Example) Crack 1 Stein = x x x x x x x x x x x Körkel, Becker, Happel & Lipsmeier (2008)

2 4 0 2 3 0 1 12 2 x x x x x x x 2 4 6 x

11 Research Questions for the Evaluation Is KISS attractive for socially excluded, heavily addicted drug users, do they cooperate and stick to the programme? Does KISS reduce substance consumption? Is KISS effective in reducing addictions? Does KISS have positive effects on other important areas in the life of addicts? How do participants evaluate the programme subjectively?

Does KISS reduce substance consumption? Is KISS effective in reducing addictions?

12 Study Design Randomized clinical trial with participants randomly assigned to either a KISS Group starting within the near future or a waiting-list control group Computer assisted personal interviews at 3 to 4 occasions: a) Pre-Assessment b) Post-Assessment (KISS-clients after completion of programme and waiting-list clients after 3 months c) Waiting-list clients after their completion of programme d) Follow-Up (6 months after last interview) Extensive urine sample analysis at each interview occasion and half way through the programme Medical checks at Pre, Post and Follow-Up

completion of programme and waiting-list clients after 3 months c) Waiting-list clients after their completion of programme d) Follow-Up (6

13 Participants of the study 230 people showed interest in KISS 123 came to an interview, 113 took part in the study 81 men, 32 women 2,5 : 1 Average age: 38.9 years 89 % detoxification, 60 % abstinence oriented therapy, 82% counselling 72 % methadone maintenance treatment 90% living on social welfare, 70% unemployed 48 % homeless 70 % single 40 % have children

9 years 89 % detoxification, 60 % abstinence oriented therapy, 82% counselling 72 %

14 Impression of KISS Group

15 Consumption Information 1 Standard Consumption Units (SCU) alcohol: 0,5 l beer 1 SCU 0,50 cannabis: 1 joint, 0,2 g 1 SCU 1,00 heroin: 1 pack, 0,2 g 1 SCU 10,00 crack: 1 stone, 0,2 g 1 SCU 10,00 cocaine: 0,2 g powder 1 SCU 20,00 benzos: 1 Rohypnol, 1mg 1 SCU 1,50

1,00 heroin: 1 pack, 0,2 g 1 SCU 10,00 crack: 1 stone, 0,2 g 1

18 Consumption Information 2 Client Nr. 64 monthly consumption at t1 alcohol 336 SCU 168 cannabis 28 SCU 28 heroin 245 SCU crack 84 SCU 840 cocaine 2 SCU 40 benzos. 56 SCU 84 total costs 3.610

19 Consumption Information 3 Number of substances used at t1 (n=113) 1 substance 13 persons 2 substances 28 persons 3 substances 28 persons 4 substances 19 persons 5 substances 16 persons 6 substances 5 persons Plus: 111 persons are smokers! 81 persons take methadone Ø 4,5 substances (we do not have reliable data for 4 persons )

substances 16 persons 6 substances 5 persons Plus: 111 persons are smokers!

20 Consumption Information 4 Substance number of Average per maximum users users amount Alcohol 45 81,66 SCU 448 SCU Cannabis 63 80,20 SCU 515 SCU Heroin 67 91,15 SCU 560 SCU Crack 70 57,55 SCU 525 SCU Cocaine 28 15,25 SCU 100 SCU Benzos 66 59,00 SCU 300 SCU n=113, monthly consumption at t1

Heroin 67 91,15 SCU 560 SCU Crack 70 57,55 SCU 525 SCU Cocaine 28 15,25

21 Consumption Frequency and Desire for Change at the Beginning of the Study all Participants, N = 113) % Consumption (last 28 days) Desire for Changes Cigarettes Crack Heroin Benzod. Cannabis Alcohol Cocaine

22 Number of KISS-Sessions attended (KISS-ITT, N= 59) Frequency KISS-Sessions attended TPP-Subsample

23 Pre-Post-Reductions in all consumption relevant alteration indicators (%) 0 Overall consumption days with consumption number of diagnosis money spent for drugs KISS-ITT Warte-KG

24 total amount of substances consumed in weighted SCU (Nutts Index) Reduction of the total amount of substances consumed KISS ITT (n=44) ITT mit Kata (n=37) WG (n=37) 156 Pre Post Follow up

25 Reduction of the total amount of money spent for drugs money spent for drugs per month in Euro KISS ITT (n=44) ITT mit Kata (n=37) WG (n=34) 310 Pre Post Follow up

26 Reduction of the number of additional diagnoses 1,7 1,6 1,63 Number of additional diagnosis 1,5 1,4 1,3 1,2 1,1 1 0,9 1,43 1,46 1,45 1 0,97 KISS ITT (n=49) ITT mit Kata (n=37) WG (n=35) 0,8 0,7 0,73 Pre Post Follow up

27 Increase in the number of consumption-free days 20 19,5 consumptionfree days per month 19 18, , , ,5 19,4 18,1 16,2 16,2 15,8 15,7 19,1 KISS ITT (n=45) ITT mit Kata (n=37) WG (n=35) 15 Pre Post Follow up

28 How strongly are you currently stressed by. Very strong not at all 0 t1 t2 t1 t2..financial situation Waiting-list KISS-TPP..legal situation

29 Subjective Evaluation of the KISS-Programme by Participants (at Post-assesement, TPP-analysis) ,7 5, ,1 5,2 5,2 4,9 4,5 Rating from 0 (very low) to 6 (very high / a lot) Satisfaction with KISS-Program overall Satisfaction with KISS-trainer KISS helped with reduction the KISS users guide? the KISS-consumption diary? the definition of weekly goals?... the consumption behaviour graph? it, to do KISS in groups? the weekly recurrence? How helpful was.

30 Conclusions Many drug addicts can be motivated to reduce their drug consumption even seemingly hopeless cases. The motivation for change is enormous (2,77 substances on average). KISS seems to work: Significant reductions in consumption level and DSM-IV addiction diagnoses. Clients (and trainers) are very satisfied with the different aspects of KISS. KISS opens the door to abstinence for some clients. KISS seems to be a suitable additional treatment option for many different settings (e.g. MMT, shelters, safe injection rooms )

31 Thank you very much for your attention! Contact: Gabi Becker, IDH Frankfurt, Germany

34 N = 113 Cl. with complete entrance diagnostics t1 N = 54 Waiting-list control group N = 59 KISS-group t2 t3 N = 46 Waiting-list control group with Post-Assesement N = 30 WL with KISS N = 20 Joined 0-3 KISS-sessions N = 55 (ITT) KISS-ITT-Cl. with Post-Assesement N = 39 Joined min 4 KISS-sessions N = 37 (TPP) KISS-TPP-Cl. with Post-Assesement t4 N = 23 KISS WL N = 8 Pure WL N = 46 KISS-ITT N = 30 KISS-TPP

35 Typical Procedure of a KISS Session 10 Final & feedback 5 Welcoming and overview 10 Flashlight 50 Working on new topic Day review & exchanges e.g.., balancing, appointing new weekly goals, choosing the strategies, personal risks, etc. 15 Break Körkel (2006)

36 Pre-Post-Reductions in all consumption relevant alteration indicators (%)

37 Changes in Addiction I: Number of DSM-IV Addiction Diagnosis at t1 (TPP, N = 83) 50 KISS-TPP (N = 37) Waiting-list (N = 46) Percent Mean KISS-TPP: 1.38 Mean Waiting-list: 1.57

38 Changes in Addiction II: Number of DSM-IV Addiction Diagnosis at t2 (TPP, N = 83) KISS-TPP (N = 37) Waiting-list (N = 46) Percent Mean KISS-TPP: 0.76 Mean Waiting-list: 1.50

OVERVIEW WHAT IS POLyDRUG USE? Different examples of polydrug use

Petrol, paint and other Polydrug inhalants use 237 11 Polydrug use Overview What is polydrug use? Reasons for polydrug use What are the harms of polydrug use? How to assess a person who uses several drugs