Substance Abuse Treatment for AdultsPhase 2NCT01948440
ASI-MV Solutions: A Tailored Program for Substance Abusers in Early Recovery
A Phase 2 study testing ASI-MV Solutions in people with Substance Abuse Treatment for Adults, run by Inflexxion, Inc..
Trial summary
Making referrals to medical and psychosocial services for substance abuse clients has proven difficult due to lack of access to services, inadequate counselor knowledge, and lack of motivation and skills among clients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Substance Abuse Treatment for Adults
- What is being tested?
- ASI-MV Solutions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jul 2013
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Client Inclusion Criteria. We will recruit participants in the same proportions as in usability testing - 40% female, 40% minorities. The inclusion criteria for clients are the same as those for usability testing, except that we will require the participant to provide: (1) the names of at least three contacts who can help locate the client during the study, and (2) multiple means of contacting them (telephone, mail, and/or email). As with usability participants, we will seek clients who are in the early stages of treatment (30 days or less, including new intakes).
Who cannot join
- None
About this study
Making referrals to medical and psychosocial services for substance abuse clients has proven difficult due to lack of access to services, inadequate counselor knowledge, and lack of motivation and skills among clients. Inflexxion is proposing the development of ASI-MV Solutions, which will educate clients about employment, legal, psychiatric, relapse prevention, medical, and family issues, as well as include resources and strategies for counselors. By linking learning modules to client results on the ASI-MV, an online interactive version of the ASI administered in treatment settings, we will be able to offer clients important tools to address key recovery issues and encourage counselors to make appropriate referrals to medical and psychosocial services.
Read the detailed description
Substance abuse research indicates that: (1) addressing medical and psychosocial problems associated with substance abuse and dependence leads to better outcomes; (2) treatments are now shorter due in part to rising healthcare costs, and it is difficult to address these issues effectively during treatment, making medical and psychosocial ("wraparound") services following treatment essential; (3) counselors may lack the knowledge to effectively integrate these services; and (4) referrals to these services have been underutilized and clients may lack the motivation, knowledge, or skills to follow up with the referrals when they are made. To address these deficits, we are proposing the development of ASI-MV Solutions, which will provide tailored motivational feedback and skill-building lessons to clients to address specific psychosocial and medical problem areas. We expect that ASI-MV Solutions will have seven modules (Alcohol, Drugs, Medical, Psychiatric, Legal, Employment, and Family) corresponding to domains of the ASI-MV, a Web-enabled interactive version of the ASI administered in treatment settings. Substance abusers who have high severity scores on ASI-MV subscales will be directed to corresponding interactive lessons and local resources on ASI-MV Solutions. To demonstrate the feasibility of the program concept, the Phase I study focused on the Employment domain. All feasibility criteria were met and findings indicated: (1) Proposed content was based on highly positive findings from concept mapping, as well as usability and acceptance testing with clients and experts. Ratings of potential effectiveness and appeal were high. (2) Usability testing indicated that the program was usable by the target audience, the skills and outcomes were relevant to the target audience, and the program was regarded as potentially very helpful to the treatment process. We surpassed feasibility benchmarks for both clients and experts. (3) Our technical/design team produced a demonstration program that was perceived by key stakeholders as highly usable and engaging multimedia program, as well as determining the necessary technologies to produce the complete program in Phase II. In Phase II we will develop ASI-MV Solutions content, complete the ASI-MV Solutions program, field test the program, and conduct satisfaction and acceptance testing of the program with clients and counselors.
- Conditions
- Substance Abuse Treatment for Adults
- Being tested
- ASI-MV Solutions
- Keywords
- Substance abuse, early recovery, relapse prevention
- 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.
ASI-MV SolutionsBehavioural
The Experimental group will complete the ASI-MV and use the ASI-MV Solutions program for eight 30-minute sessions, followed by monthly booster sessions. The Experimental group will undergo a baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention.
| Study group | Role | What they receive |
|---|---|---|
| ASI-MV Solutions | Experimental | The Experimental group will complete the ASI-MV and use the ASI-MV Solutions program for eight 30-minute sessions, followed by monthly booster sessions. The Experimental group will undergo a baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention. Receives: Behavioral: ASI-MV Solutions |
| Treatment as Usual | No intervention | The Control group participants will complete the ASI-MV and receive their normal course of treatment. The Control group will undergo a baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
improved outcomes, as measured by substance use, psychosocial, and psychological functioning
Addiction Severity Index - Multimedia Version (ASI-MV)
Measured: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
greater problem-services matching, as measured by the number and fit of referred/received services
Treatment Services Checklist (Client Version) and Treatment Services Checklist (Counselor Version).
Measured: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
greater treatment motivation
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES, Version 8D; Miller \& Tonigan, 1996)
Measured: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
greater self-efficacy in managing psychosocial issues
Drug Avoidance Self-Efficacy Scale
Measured: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
Secondary outcomes (2)
treatment compliance
Treatment Compliance: We will ask counselors to record scheduled and planned sessions within the treatment facility as a way of assessing treatment compliance. We will also ask counselors to record client reasons for leaving treatment prematurely (Against Medical Advice, moving, hospitalization, etc.).
Measured: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
treatment alliance with counselors
Working Alliance Inventory-Short Form (Clients) and Working Alliance Inventory-Short Form (Counselors)
Measured: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startJul 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Abuse Treatment for AdultsStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflexxion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Emil Chiauzzi, Inflexxion, Inc.
- Investigators
- Emil Chiauzzi, PhD, Principal investigator, Inflexxion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948440
- Sponsor's protocol ID
- 2R44DA026232-02
- Status last verified
- Sep 2013
- First submitted
- 27 Jul 2010
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASI-MV Solutions: A Tailored Program for Substance Abusers in Early Recovery
- ClinicalTrials.gov ID
- NCT01948440
- Acronym / sponsor ID
- 2R44DA026232-02
- Conditions
- Substance Abuse Treatment for Adults
- Keywords
- Substance abuse, early recovery, relapse prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Inflexxion, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Sep 2013 (estimated)
- 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.
Making referrals to medical and psychosocial services for substance abuse clients has proven difficult due to lack of access to services, inadequate counselor knowledge, and lack of motivation and skills among clients. Inflexxion is proposing the development of ASI-MV Solutions, which will educate clients about employment, legal, psychiatric, relapse prevention, medical, and family issues, as well as include resources and strategies for counselors. By linking learning modules to client results on the ASI-MV, an online interactive version of the ASI administered in treatment settings, we will be able to offer clients important tools to address key recovery issues and encourage counselors to make appropriate referrals to medical and psychosocial services.
Detailed description
Substance abuse research indicates that: (1) addressing medical and psychosocial problems associated with substance abuse and dependence leads to better outcomes; (2) treatments are now shorter due in part to rising healthcare costs, and it is difficult to address these issues effectively during treatment, making medical and psychosocial ("wraparound") services following treatment essential; (3) counselors may lack the knowledge to effectively integrate these services; and (4) referrals to these services have been underutilized and clients may lack the motivation, knowledge, or skills to follow up with the referrals when they are made. To address these deficits, we are proposing the development of ASI-MV Solutions, which will provide tailored motivational feedback and skill-building lessons to clients to address specific psychosocial and medical problem areas. We expect that ASI-MV Solutions will have seven modules (Alcohol, Drugs, Medical, Psychiatric, Legal, Employment, and Family) corresponding to domains of the ASI-MV, a Web-enabled interactive version of the ASI administered in treatment settings. Substance abusers who have high severity scores on ASI-MV subscales will be directed to corresponding interactive lessons and local resources on ASI-MV Solutions. To demonstrate the feasibility of the program concept, the Phase I study focused on the Employment domain. All feasibility criteria were met and findings indicated: (1) Proposed content was based on highly positive findings from concept mapping, as well as usability and acceptance testing with clients and experts. Ratings of potential effectiveness and appeal were high. (2) Usability testing indicated that the program was usable by the target audience, the skills and outcomes were relevant to the target audience, and the program was regarded as potentially very helpful to the treatment process. We surpassed feasibility benchmarks for both clients and experts. (3) Our technical/design team produced a demonstration program that was perceived by key stakeholders as highly usable and engaging multimedia program, as well as determining the necessary technologies to produce the complete program in Phase II. In Phase II we will develop ASI-MV Solutions content, complete the ASI-MV Solutions program, field test the program, and conduct satisfaction and acceptance testing of the program with clients and counselors.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASI-MV Solutions | Experimental | Behavioral: ASI-MV SolutionsThe Experimental group will complete the ASI-MV and use the ASI-MV Solutions program for eight 30-minute sessions, followed by monthly booster sessions. The Experimental group will undergo a baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention. |
| Treatment as Usual | No intervention | –The Control group participants will complete the ASI-MV and receive their normal course of treatment. The Control group will undergo a baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Client Inclusion Criteria. We will recruit participants in the same proportions as in usability testing - 40% female, 40% minorities. The inclusion criteria for clients are the same as those for usability testing, except that we will require the participant to provide: (1) the names of at least three contacts who can help locate the client during the study, and (2) multiple means of contacting them (telephone, mail, and/or email). As with usability participants, we will seek clients who are in the early stages of treatment (30 days or less, including new intakes).
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ASI-MV SolutionsThe Experimental group will complete the ASI-MV and use the ASI-MV Solutions program for eight 30-minute sessions, followed by monthly booster sessions. The Experimental group will undergo a baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention. | Behavioural | ASI-MV Solutions |
Primary outcome
improved outcomes, as measured by substance use, psychosocial, and psychological functioning
Time frame: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
Addiction Severity Index - Multimedia Version (ASI-MV)
greater problem-services matching, as measured by the number and fit of referred/received services
Time frame: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
Treatment Services Checklist (Client Version) and Treatment Services Checklist (Counselor Version).
greater treatment motivation
Time frame: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES, Version 8D; Miller \& Tonigan, 1996)
greater self-efficacy in managing psychosocial issues
Time frame: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
Drug Avoidance Self-Efficacy Scale
2 secondary outcomes
treatment compliance
Time frame: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
treatment alliance with counselors
Time frame: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
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 23 Sep 2013.
Related trials for Substance Abuse Treatment for Adults
Not yet recruiting
QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 4
E-cigarette Cessation in Adults Who Co-use Cannabis
Nicotine Dependence, Tobacco Use Disorder
RecruitingPhase 2
Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder
Cannabis Use Disorder, Cannabis Use Disorders
RecruitingPhase 2
Investigating a Marijuana-based Compound as a Treatment for Anxiety in Autistic Adults
Autism Spectrum Disorder, Anxiety
Recruiting
Virtual Incentive Treatment for Alcohol
Alcohol Use Disorder, Alcohol Drinking
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.
Emil Chiauzzi, PhD principal investigator
Inflexxion, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASI-MV Solutions in people with Substance Abuse Treatment for Adults, run by Inflexxion, Inc..
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 1 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 23 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
improved outcomes, as measured by substance use, psychosocial, and psychological functioning (time frame: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention). The study lists 4 primary outcomes in all. 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 23 Sep 2013.