Substance Use DisordersNCT03623178
Assertive Community Treatment for Patients Suffering From Substance Use Disorders
An observational study of Substance Use Disorders, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
According to the World Health Organization the population suffering from addiction problems is increasing. This population is characterized by multiple needs at the medico-psychosocial level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Assertive Community Treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2017to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subgroup of high need users with difficulties in engaging in substance use disorder treatment.
Who may be able to join
- Substance use disorder
- Competent subjects, able to give informed consent
- French speaking
Who cannot join
- Evidence of organic brain disease or learning disability based on the chart review.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assertive Community Treatment for Patients Suffering From Substance Use
According to the World Health Organization the population suffering from addiction problems is increasing. This population is characterized by multiple needs at the medico-psychosocial level. However, some of these patients, a particular subgroup that we are going to be interested in the so-called "high need" user group, find it difficult to access and stay in outpatient treatment programs. Persons with substance use disorder often present a chaotic use of the health system, including a high number of hospitalizations in times of crisis. These individuals also show very low utilization of health care services, accompanied by social marginalization. This can be related to relapses and poor social functioning. A high number of relapses occur particularly at the end of hospitalization. Community Interventions, such as Assertive Community Treatment (ACT) should increase the adherence of these patients to treatment by accompanying them in the community and helping them during sensitive and crisis periods. One of the objectives of the study is to evaluate the impact of ACT on the time until service disengagement, measuring treatment adherence. The secondary objectives of this study will be to see the effect of ACT on duration and type of hospitalizations, as well as the number of emergency room visits. The investigators will focus on the impact of ACT on the participant's medico-psycho-social network, substance use and other psychological variables. The investigators will also evaluate his or her psychiatric symptoms and global and social functioning. Life satisfaction and satisfaction with the care received will also be measured. The study will investigate this through questionnaires at the beginning of care, at three months, six months and 12 months after the start of the ACT intervention.
- Conditions
- Substance Use Disorders
- Being tested
- Assertive Community Treatment
- Keywords
- Substance Use Disorders, Assertive Community Treatment, Community Treatment, Treatment engagement, Service Use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assertive Community TreatmentOther
The intervention program is a type of very flexible community treatment. This is facilitated by a small case load ratio per health care professional (1:10). The healthcare workers are specialized in SUD treatment. The time of the intervention differs, there is no prefixed limitation but the duration of the intervention depends on the goals agreed on with the patient. The main objective of this intervention is to ensure an adherence to an addiction treatment program and establish or consolidate a stable healthcare and social network for the patient. The intervention aims to prevent service disengagement. The healthcare workers will explore specific patient needs and ensure that health and social services are better coordinated to fit their needs.
| Study group | Role | What they receive |
|---|---|---|
| Assertive Community Treatment | patients with DSM-5 Diagnosis of SUD and one of the following criteria (1) present important functional difficulties, in at least one of the following areas: everyday life activities and maintaining a supportive social network, for minimum two years.
or (2) difficulties to attend their health care appointments, during the last 3 months. Receives: Other: Assertive Community Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment adherence
Number of days until service disengagement
Measured: at 12 months
Secondary outcomes (7)
Service use
Number of hospital admissions and number of days in hospital
Measured: at 12 months
Patient network
Number of persons in network
Measured: 0, 3, 6, 12 months
Number of ER visits
Number of ER visits reviewed on patient file
Measured: 0, 3, 6, 12 months
Addictive behaviour
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST. V.3 French)
Measured: 0, 3, 6, 12 months
General psychiatric symptoms
Health of Nation Outcome Scale - French version (HoNOS-F): scores 0 - 52 (higher score = more psychiatric symptoms)
Measured: 0, 3, 6, 12 months
Global Functioning
World Health Organization Disability Assessment Schedule (WHODAS)
Measured: 0, 3, 6, 12 months
General life satisfaction: Satisfaction With Life Scale
Satisfaction With Life Scale: scores 5 - 35 (higher score = higher life satisfaction)
Measured: 0, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Dec 2017
- Primary completion1 Jan 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Penzenstadler, University Hospital, Geneva
- Investigators
- Louise Penzenstadler, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623178
- Sponsor's protocol ID
- ID 2017-01087
- Status last verified
- Aug 2018
- First submitted
- 1 Aug 2018
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assertive Community Treatment for Patients Suffering From Substance Use
- ClinicalTrials.gov ID
- NCT03623178
- Acronym / sponsor ID
- ID 2017-01087
- Conditions
- Substance Use Disorders
- Keywords
- Substance Use Disorders, Assertive Community Treatment, Community Treatment, Treatment engagement, Service Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to the World Health Organization the population suffering from addiction problems is increasing. This population is characterized by multiple needs at the medico-psychosocial level. However, some of these patients, a particular subgroup that we are going to be interested in the so-called "high need" user group, find it difficult to access and stay in outpatient treatment programs. Persons with substance use disorder often present a chaotic use of the health system, including a high number of hospitalizations in times of crisis. These individuals also show very low utilization of health care services, accompanied by social marginalization. This can be related to relapses and poor social functioning. A high number of relapses occur particularly at the end of hospitalization. Community Interventions, such as Assertive Community Treatment (ACT) should increase the adherence of these patients to treatment by accompanying them in the community and helping them during sensitive and crisis periods. One of the objectives of the study is to evaluate the impact of ACT on the time until service disengagement, measuring treatment adherence. The secondary objectives of this study will be to see the effect of ACT on duration and type of hospitalizations, as well as the number of emergency room visits. The investigators will focus on the impact of ACT on the participant's medico-psycho-social network, substance use and other psychological variables. The investigators will also evaluate his or her psychiatric symptoms and global and social functioning. Life satisfaction and satisfaction with the care received will also be measured. The study will investigate this through questionnaires at the beginning of care, at three months, six months and 12 months after the start of the ACT intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assertive Community Treatment | – | Other: Assertive Community Treatmentpatients with DSM-5 Diagnosis of SUD and one of the following criteria (1) present important functional difficulties, in at least one of the following areas: everyday life activities and maintaining a supportive social network, for minimum two years. or (2) difficulties to attend their health care appointments, during the last 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subgroup of high need users with difficulties in engaging in substance use disorder treatment.
Key inclusion criteria (3 listed)
- Substance use disorder
- Competent subjects, able to give informed consent
- French speaking
Key exclusion criteria (1 listed)
- Evidence of organic brain disease or learning disability based on the chart review.
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 |
|---|---|---|
| Assertive Community TreatmentThe intervention program is a type of very flexible community treatment. This is facilitated by a small case load ratio per health care professional (1:10). The healthcare workers are specialized in SUD treatment. The time of the intervention differs, there is no prefixed limitation but the duration of the intervention depends on the goals agreed on with the patient. The main objective of this intervention is to ensure an adherence to an addiction treatment program and establish or consolidate a stable healthcare and social network for the patient. The intervention aims to prevent service disengagement. The healthcare workers will explore specific patient needs and ensure that health and social services are better coordinated to fit their needs. | Other | Assertive Community Treatment |
Primary outcome
Treatment adherence
Time frame: at 12 months
Number of days until service disengagement
7 secondary outcomes
Service use
Time frame: at 12 months
Patient network
Time frame: 0, 3, 6, 12 months
Number of ER visits
Time frame: 0, 3, 6, 12 months
Addictive behaviour
Time frame: 0, 3, 6, 12 months
General psychiatric symptoms
Time frame: 0, 3, 6, 12 months
Global Functioning
Time frame: 0, 3, 6, 12 months
General life satisfaction: Satisfaction With Life Scale
Time frame: 0, 3, 6, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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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.
Louise Penzenstadler, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders, run by University Hospital, Geneva at 1 site in Switzerland.
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 3 inclusion and 1 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 21 May 2025. 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 Switzerland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment adherence (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2025.