An interventional study of Fully integrated treatment and Stand-alone Intensive Outpatient Program in Alcohol Use Disorder and Social Anxiety Disorder, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-11-01.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
Among 19 studies in Alcoholism by University of California, Los Angeles — 3 open to participants now, 5 under way, 1 of them phase 3. Alcoholism · University of California, Los Angeles.
Among the 19 studies in Alcoholism by University of California, Los Angeles, this one is the 9th largest by enrollment of the 17 interventional ones that give a count, is one of 4 that started in 2018, is one of 3 with no phase, and was the 9th registered.
1,676 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
Browse Alcoholism studies →3 of the 19 studies in Alcoholism by University of California, Los Angeles are open now, in 1 country. Recruiting first, the newest first:
University of California, Los Angeles · Sites in United States
Ages 18+ · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 21–65
University of California, Los Angeles
Ages 21–65 · Healthy volunteers
By country, each count listing its studies:
Of the 237 Alcoholism studies recruiting now, 84 (35%) set no upper age limit and 131 (55%) stop at 75 or younger; 9 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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19 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 11 · Phase 3 2
First in 2007; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 56 is below the median of 88 across 1,430 interventional studies indexed under Alcoholism.
Median enrollment 56 across the 17 interventional studies, 945 across the 2 observational. Of the 12 that completed or were terminated, 7 (58%) have results posted.
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University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
1 of the studies in Alcoholism by University of California, Los Angeles that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06494891University of California, Los AngelesMotivation for IV Alcohol Self-Administration in Humans | 2027-04-30 |
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Among the 19 studies in Alcoholism by University of California, Los Angeles, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Alcohol use disorders (AUD) and social anxiety disorder (SAD) are highly comorbid and associated with significant impairment. Social anxiety comorbidity is associated with poorer addiction treatment engagement and outcomes. Thus, addressing underlying SAD symptoms that may lead to and maintain alcohol problems, as well as undermine successful treatment for AUD, is warranted. This proposal aims to develop and evaluate a fully integrated outpatient program for comorbid SAD and AUD that weaves evidence-based treatment for SAD (i.e., exposure-based cognitive behavioral therapy) into a traditional, evidence-based treatment for AUD.
First, the investigators will develop the protocol for the fully integrated treatment (FIT). The overarching goal of FIT will be to simultaneously deliver AUD and SAD treatment. Development will be an iterative process guided by previous research (including our own), and by input from clinicians, administrators, and patients in an outpatient substance use disorder treatment clinic. After the protocol is developed, the investigators will use their established clinician training procedures to train clinicians at their community partnered clinic to competently deliver the intervention. After protocol development and clinician training, the investigators will conduct a pilot randomized clinical trial (RCT) comparing the efficacy of our fully integrated treatment (FIT) for comorbid alcohol use and social anxiety disorders to usual care (UC) in the community substance use disorder specialty clinic. The goals of the RCT will be to gather data regarding acceptability, feasibility, and preliminary efficacy of the FIT protocol. The investigators will randomize treatment-seeking participants (N = 60) who have comorbid SAD and AUD. The investigators will assess treatment engagement, social anxiety outcomes, and alcohol use outcomes at baseline, 3-months, and 6-months from baseline. The investigators will also gather qualitative and quantitative acceptability data from patients after completing FIT, which may guide final refinements of FIT prior to testing in a larger-scale grant.
The knowledge gained from this investigation has the potential to significantly improve the treatment of alcohol use disorders and make a significant public health impact. The focus on direct translation to community practice paradigms and the emphasis on full mental health and addiction treatment integration significantly advance the field.
In this study, potential participants will be screened either by University of California, Los Angeles (UCLA) staff or at the Matrix Institute on Addiction to determine whether they may have social anxiety and alcohol use disorder symptoms. If they screen positive for these symptoms, they will be invited to come in for a comprehensive baseline assessment consisting of interviews, questionnaires, and a behavioral assessment. Eligible participants will be randomly assigned to either receive standard Matrix treatment consisting of a 9-hour per week Intensive Outpatient Program (IOP) lasting approximate 2-3 months; or FIT, an Intensive Outpatient Program (also 9 hours per week for approximately 2-3 months) consisting of cognitive behavioral therapy (CBT) for social anxiety disorder that is woven into the alcohol recovery program. After treatment, participants will complete another assessment, and then will complete one several months later.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Evidence-based substance use treatment combined with Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder Intervention name: Fully integrated treatment
Behavioral: Fully integrated treatment
Evidence-based substance use disorder treatment Intervention name: Stand-alone Intensive Outpatient Program
Behavioral: Stand-alone Intensive Outpatient Program
Clinicians will be delivering CBT for Social Anxiety Disorder directly into the context of the Matrix's evidence-based treatment for substance use disorders (i.e., The Matrix Model).
Evidence-based treatment for substance use disorders (i.e., The Matrix Model).
Change from Baseline Alcohol consumption at 3 and 6 months
The Timeline Followback (TLFB), a gold standard semi-structured interview measure of alcohol consumption, will be used in order to obtain number of drinking days
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Social Anxiety Symptoms in Situations at 3 and 6 months
The Leibowitz Social Anxiety Scale-Self Report (LSAS-SR) will be used to assess the extent to which individuals are anxious in, and avoid, a variety of social situations, including performance based and social-interactional situations. Anxiety and avoidance are each rated from 1 (none/never) to 4 (extreme/always) Higher scores indicate greater severity of social anxiety.
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Social anxiety-related drinking motives at 3 and 6 months
This will be assessed using the Drinking to Cope with Social Anxiety Scale (DCSAS), which measures drinking behavior in social situations. The score on the measure is out of 72, with a minimum score of 0 indicating the least amount of avoidance/drinking to scope in situations, and 72 indicating the most amount of avoidance/drinking to scope in situations
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Quality of Life and overall functioning at 3 and 6 months
This will be assessed using the Short Form (SF-8), which is a generic quality of life measure with 8 items. The total score is out of 41, with a minimum score of 8 indicating best quality of life score and a maximum score or 41 indicating worst quality of life score.
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Alcohol Problems at 3 and 6 months
The Short Inventory of Problems, a dimensional measure of alcohol-related consequences, will be used using "past month" as the time frame for each assessment.
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Alcohol Drinks per Day at 3 and 6 months
The Timeline Followback (TLFB) will be used in order to obtain average drinks per drinking day
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Heavy Alcohol Use Days at 3 and 6 months
The Timeline Followback (TLFB) will be used in order to obtain % of heavy drinking days (defined as ≥4 drinks per day for women and ≥5 drinks per day for men)
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Alcohol Abstinence at 3 and 6 months
The Timeline Followback (TLFB) will be used in order to obtain sustained abstinence (v. not) during the past 30 days
Time frame: Baseline, 3 months, and 6 months
Change from Baseline Social Anxiety Symptom Severity at 3 and 6 months
The Behavioral Approach Task (BAT), a validated behavioral assessment of social anxiety severity, will be used.
Time frame: Baseline, 3 months, and 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Dec 2020, 32 months.
Of 470 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 54. This study's 32 months is close to that.
Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles →