NCT06030154 Amplification of Positivity for Alcohol Use

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 100 participants in total. It began in 2023-09-25 with a primary completion date of 2026-07.

Brief Summary

The proposed study consists of two phases. During Phase 1, the investigators will recruit a small sample of participants to complete a psychosocial intervention termed Amplification of Positivity (AMP) for individuals experiencing comorbid depression or anxiety disorders and alcohol use disorder (AMP-A). These participants will be asked to provide both qualitative and quantitative input about the AMP-A intervention. Based on their input and clinician input, the AMP-A manual will be modified for use in Phase 2. The goal is to recruit up to 20 participants in order to ensure there will be at least 8 participants who complete all sessions of AMP-A. Phase 2 is a randomized clinical trial (RCT) protocol in which individuals experiencing comorbid depression or anxiety disorders and alcohol use disorder will be randomized to complete AMP-A or an evidence-based cognitive-behavioral therapy (CBT) intervention. Up to 100 participants will be recruited in order to reach a target of N=60. Assessed outcomes will include participant acceptability and completion rates, participant compliance with the intervention, positive and negative affect, substance use- and depression and anxiety-related symptom severity, functional disability, and neural reactivity to reward and alcohol cues during functional magnetic resonance imaging (fMRI).

Eligibility Criteria

Inclusion Criteria: 1. Age between 18 and 65 years old. 2. Meeting diagnostic criteria for alcohol use disorder 42 according to the DSM-5. 3. Reports that they would like to seek treatment for AUD and that AUD is one of the primary challenges they would like to address in treatment. 4. Phase 1: Significant depression or anxiety symptoms as indexed by scoring Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8. Phase 2: Significant depression or anxiety symptoms as indexed by scoring ≥ 55 on either of the NIH PROMIS ((Patient-Reported Outcomes Measurement Information System) Depression and/or Anxiety scales. 5. Below normative levels of positive affect as indexed by PROMIS Positive Affect \<50. 6. Able to provide written informed consent. 7. Have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures. Exclusion Criteria: 1. Unwillingness or inability to complete any of the major aspects of the study protocol, including self-report or behavioral assessment. However, failing to complete some individual aspects of these assessment sessions will be acceptable (i.e., being unwilling to answer individual items on some questionnaires or being unwilling to complete a behavioral task). In addition, the neuroimaging portion of the protocol will be optional. 2. Non-correctable vision or hearing problems that interfere with the participant's ability to complete study assessments. 3. No telephone or easy access to telephone. 4. Diagnosis of Schizophrenia spectrum, other psychotic disorders, obsessive-compulsive disorder, eating disorders, substance use disorders within the past year other than alcohol use disorder or cannabis use disorder, or bipolar I disorder. Mild binge eating disorder will be considered for inclusion on a case-by-case basis at the discretion of the PI. 5. Active suicidal ideation with plan and intent to attempt suicide within the next month. 6. Has a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments. 7. A positive test for drugs of abuse, including alcohol (breath test) and substances of dependence that are not physician prescribed (i.e., cocaine, cannabis, opioids, stimulants).at the time of baseline assessments. Participants will be asked to refrain from using alcohol within 24 hours prior to assessment sessions and to refrain from using marijuana within 48 hours of assessment sessions. 8. Current use of a medication within the 6 weeks prior to enrolling in the study that could potentially affect brain functioning and/or the positive valence system (e.g., anxiolytics, antipsychotics, mood stabilizers, opioid antagonists such as naltrexone or other medications specifically targeting alcohol use or cravings). The current use of antidepressants (i.e., SSRIs), benzodiazepines, and psychostimulants will not be excluded as long as the dose has remained consistent for 6 weeks prior to baseline assessment sessions. Individuals who are on stable doses (≥ 6 weeks) of mood stabilizers or antipsychotics may be included if it is determined that they are being prescribed for purposes of treating unipolar depression or anxiety. Inclusion of individuals reporting other types of medications or supplements not listed or considered this far will be at the discretion of the PI according to evidence in the literature of it affecting brain function or brain blood flow. 9. Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, and excessive caffeine intake \> 1000 mg/day) - Phase 2 only 10. Concurrent engagement in psychosocial treatments that specifically target alcohol use disorder or mood/anxiety symptoms and began within 12 weeks of baseline assessments. Individuals concurrently receiving psychosocial treatments for other symptoms, or that are not specifically targeting symptoms (e.g., ongoing support groups) will not be excluded as long as the dose of treatment (i.e., frequency of sessions) has not changed significantly within 6 weeks prior to enrolling in the study. 11. MRI contraindications (for those in Phase 2 opting into this portion) including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a professional metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60-120 minutes; prior neurosurgery; tattoos or cosmetic makeup with metal dyes, unwillingness to remove body piercings, and pregnancy - Phase 2 only 12. Moderate to severe traumatic brain injury (\>30 min. loss of consciousness or \>24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits, neurological disorders, or severe or unstable medical conditions that might be compromised by participation in the study (to be determined by primary care provider). 13. Severity of alcohol use disorder requiring more intensive treatment (i.e., intensive outpatient or residential), as determined by licensed clinician determination of American Society of Addiction Medicine (ASAM) Criteria ≥ 0-1 across dimensions, with the exception of a '2' on the emotional dimension. 14. Given the current study involves development of the positive affect intervention, we will not enroll any special vulnerable populations (pregnant women, fetuses, neonates, prisoners, children).

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