Substance-related DisordersNCT04969081
Impact of Work Activity on SUD Outcomes
A study testing referral to work focused program and treatment as usual in people with Substance-related Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
To date, there are no studies of the therapeutic effects of varied work-focused programs in Veterans undergoing outpatient substance use disorder (SUD) treatment. The investigators propose a randomized clinical trial to test the effects of work-focused programs on improving sobriety and other clinical outcomes in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance-related Disorders
- What is being tested?
- referral to work focused program and treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2022to 10 Aug 2026
- Phase
- Interventional
- 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
Who may be able to join
- Participants will be Veterans enrolled in VACHS substance use treatment, who at time of consenting into the study are within 30 days of detoxification or last substance use as per medical record.
- Additional criteria will be as follows:
- Meeting DSM-V criteria for any current Substance Use Disorder (SUD) (e.g., opioids, cocaine, marijuana, amphetamine, or alcohol)
- Competent to give written informed consent and HIPAA authorization
Who cannot join
- Involvement in a legal case that may lead to incarceration during study period
- Developmental disability or medical illness that would prevent therapeutic work activity, as judged by PI or clinical staff providing this service
- Plans to relocate outside geographic area that would make follow-up unlikely
- And/or lack of willingness to provide contact information of someone who can help us contact the participant in the event that the investigators are unable to maintain contact directly
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
About this study
Official title: Augmenting Early Phase Substance Use Treatment With Therapeutic Work Activity to Improve Clinical Outcomes: a New Indication for an Old Intervention
To date, there are no studies of the therapeutic effects of varied work-focused programs in Veterans undergoing outpatient substance use disorder (SUD) treatment. The investigators propose a randomized clinical trial to test the effects of work-focused programs on improving sobriety and other clinical outcomes in Veterans early in the course of recovery from SUD. Veterans will be randomized to either receive or not receive referral for work-focused therapeutic programs. Primary aim is to examine effects of work-focused programs on sobriety outcomes, namely sobriety and global functioning. Secondary aim is to examine effects of work-focused programs on psychiatric symptoms, self esteem/efficacy, and quality of life.
Read the detailed description
The investigators propose a trial to test the effects of Incentive Therapy (IT) and Other Therapeutic and Supported Employment Services (Other TSES) on improving SUD outcomes in newly recovering Veterans in outpatient treatment. In line with eligibility criteria for different TSES programs, the investigators will employ a two branch study: One branch will be for Veterans who are not interested in pursuing competitive employment, and will be a two arm RCT with randomization (2:1) to referral for IT + treatment as usual (TAU; including usual SUD outpatient treatment) or TAU alone. The second branch will be for Veterans who express interest in competitive employment, and will be a two arm Randomized Controlled Trial (RCT) with randomization (2:1) to referral for TSES competitive employment services + TAU or TAU alone. Total Intent to Treat sample will be 140 (n=70 per branch). Primary outcomes will be percent days abstinent during 3 month active phase and clinical global impression scale scores at 6 months. Secondary outcome will be psychiatric symptoms, self esteem/efficacy and quality of life.
- Conditions
- Substance-related Disorders
- Being tested
- referral to work focused program, treatment as usual
- Keywords
- substance-related disorders, rehabilitation, vocational
- 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.
referral to work focused programBehavioural
referral to Incentive Therapy or to Other Therapeutic and Supported Employment Services
treatment as usualOther
usual treatment
| Study group | Role | What they receive |
|---|---|---|
| treatment as usual | Active comparator | usual substance use treatment Receives: Other: treatment as usual |
| treatment as usual plus referral to work focused program | Experimental | usual substance use treatment plus referral to a competitive or non-competitive work-focused program Receives: Behavioral: referral to work focused program; Other: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent days abstinent
percent days abstinent during 3-month active phase
Measured: 3 months
Clinical Global Impression
Clinical Global Impression ratings conducted at 6 months from study entry.
Measured: 6 months
Secondary outcomes (4)
change from baseline in BASIS-24
change in Behavior and Symptom Identification Scale, self-report
Measured: 3 months
change from baseline in Rosenberg self-esteem scale
change in self report of self-esteem
Measured: 6 months
change from baseline in New General Self-Efficacy Scale
change in self-report of self-efficacy
Measured: 6 months
change in WHOQOL BREF
change in self-report of quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start3 Jan 2022
- Primary completion31 Jul 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance-related DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two branch study: one branch for Veterans not interested in competitive employment, and one for Veterans interested in competitive employment. Within each branch, Veterans will be randomized to either treatment as usual, or treatment as usual plus referral to competitive or non-competitive work-focused program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joanna M. Fiszdon, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969081
- Sponsor's protocol ID
- D3493-R
- Status last verified
- Sep 2026
- First submitted
- 1 Jul 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, anonymized dataset will be created. This dataset may be shared with other investigators, upon written request, under a data use agreement prohibiting the recipient from identifying or re-de-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. The data sharing agreement will also restrict redistribution to third parties and proper acknowledgment of the data source. These datasets will be shared per guidelines provided by VACHS Information Security Officer.
Publications
Schrader SW, Bell MD, Reilly SE, Weinstein AJ, Fiszdon JM. Work and recovery from substance use disorder in Veterans Affairs: Characteristics of veterans seeking work therapy and vocational rehabilitation. Psychiatr Rehabil J. 2025 Aug 21:10.1037/prj0000662. doi: 10.1037/prj0000662. Online ahead of print.
PubMed 40839470
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Early Phase Substance Use Treatment With Therapeutic Work Activity to Improve Clinical Outcomes: a New Indication for an Old Intervention
- ClinicalTrials.gov ID
- NCT04969081
- Acronym / sponsor ID
- D3493-R
- Conditions
- Substance-related Disorders
- Keywords
- substance-related disorders, rehabilitation, vocational
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 20 Jul 2021 (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.
To date, there are no studies of the therapeutic effects of varied work-focused programs in Veterans undergoing outpatient substance use disorder (SUD) treatment. The investigators propose a randomized clinical trial to test the effects of work-focused programs on improving sobriety and other clinical outcomes in Veterans early in the course of recovery from SUD. Veterans will be randomized to either receive or not receive referral for work-focused therapeutic programs. Primary aim is to examine effects of work-focused programs on sobriety outcomes, namely sobriety and global functioning. Secondary aim is to examine effects of work-focused programs on psychiatric symptoms, self esteem/efficacy, and quality of life.
Detailed description
The investigators propose a trial to test the effects of Incentive Therapy (IT) and Other Therapeutic and Supported Employment Services (Other TSES) on improving SUD outcomes in newly recovering Veterans in outpatient treatment. In line with eligibility criteria for different TSES programs, the investigators will employ a two branch study: One branch will be for Veterans who are not interested in pursuing competitive employment, and will be a two arm RCT with randomization (2:1) to referral for IT + treatment as usual (TAU; including usual SUD outpatient treatment) or TAU alone. The second branch will be for Veterans who express interest in competitive employment, and will be a two arm Randomized Controlled Trial (RCT) with randomization (2:1) to referral for TSES competitive employment services + TAU or TAU alone. Total Intent to Treat sample will be 140 (n=70 per branch). Primary outcomes will be percent days abstinent during 3 month active phase and clinical global impression scale scores at 6 months. Secondary outcome will be psychiatric symptoms, self esteem/efficacy and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two branch study: one branch for Veterans not interested in competitive employment, and one for Veterans interested in competitive employment. Within each branch, Veterans will be randomized to either treatment as usual, or treatment as usual plus referral to competitive or non-competitive work-focused program.
| Arm | Type | Receives |
|---|---|---|
| treatment as usual | Active comparator | Other: treatment as usualusual substance use treatment |
| treatment as usual plus referral to work focused program | Experimental | Behavioral: referral to work focused program, Other: treatment as usualusual substance use treatment plus referral to a competitive or non-competitive work-focused program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants will be Veterans enrolled in VACHS substance use treatment, who at time of consenting into the study are within 30 days of detoxification or last substance use as per medical record.
- Additional criteria will be as follows:
- Meeting DSM-V criteria for any current Substance Use Disorder (SUD) (e.g., opioids, cocaine, marijuana, amphetamine, or alcohol)
- Competent to give written informed consent and HIPAA authorization
Key exclusion criteria (4 listed)
- Involvement in a legal case that may lead to incarceration during study period
- Developmental disability or medical illness that would prevent therapeutic work activity, as judged by PI or clinical staff providing this service
- Plans to relocate outside geographic area that would make follow-up unlikely
- And/or lack of willingness to provide contact information of someone who can help us contact the participant in the event that the investigators are unable to maintain contact directly
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 |
|---|---|---|
| referral to work focused programreferral to Incentive Therapy or to Other Therapeutic and Supported Employment Services | Behavioural | treatment as usual plus referral to work focused program |
| treatment as usualusual treatment | Other | treatment as usual, treatment as usual plus referral to work focused program |
Primary outcome
percent days abstinent
Time frame: 3 months
percent days abstinent during 3-month active phase
Clinical Global Impression
Time frame: 6 months
Clinical Global Impression ratings conducted at 6 months from study entry.
4 secondary outcomes
change from baseline in BASIS-24
Time frame: 3 months
change from baseline in Rosenberg self-esteem scale
Time frame: 6 months
change from baseline in New General Self-Efficacy Scale
Time frame: 6 months
change in WHOQOL BREF
Time frame: 6 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 9 Sep 2026.
- Background: PubMed 40839470Schrader SW, Bell MD, Reilly SE, Weinstein AJ, Fiszdon JM. Work and recovery from substance use disorder in Veterans Affairs: Characteristics of veterans seeking work therapy and vocational rehabilitation. Psychiatr Rehabil J. 2025 Aug 21:10.1037/prj0000662. doi: 10.1037/prj0000662. Online ahead of print.
- Individual participant dataSharing planned: Yes. De-identified, anonymized dataset will be created. This dataset may be shared with other investigators, upon written request, under a data use agreement prohibiting the recipient from identifying or re-de-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. The data sharing agreement will also restrict redistribution to third parties and proper acknowledgment of the data source. These datasets will be shared per guidelines provided by VACHS Information Security Officer.
Related trials for Substance-related Disorders
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
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.
Joanna M. Fiszdon, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing referral to work focused program and treatment as usual in people with Substance-related Disorders, run by VA Office of Research and Development 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 4 inclusion and 4 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 9 Sep 2026. 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.
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?
percent days abstinent (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT04969081, 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 9 Sep 2026.