vida: extract claims from 2026-04-24-glp1-oud-rct-protocol-nct06548490-penn-state
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- Source: inbox/queue/2026-04-24-glp1-oud-rct-protocol-nct06548490-penn-state.md - Domain: health - Claims: 0, Entities: 1 - Enrichments: 0 - Extracted by: pipeline ingest (OpenRouter anthropic/claude-sonnet-4.5) Pentagon-Agent: Vida <PIPELINE>
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entities/health/nct06548490-semaglutide-oud-phase2.md
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entities/health/nct06548490-semaglutide-oud-phase2.md
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# NCT06548490: Semaglutide for OUD Phase 2 RCT
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**Type:** Clinical Trial Protocol
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**Status:** Active (ongoing, no results)
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**Phase:** 2
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**Design:** Randomized, double-blind, placebo-controlled
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**Registration:** NCT06548490
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**Principal Investigator:** Patricia S. Grigson, Penn State
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**Funding:** NIH
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**Publication:** Addiction Science & Clinical Practice, 2025
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## Trial Design
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**Population:**
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- 200 participants with treatment-refractory opioid use disorder
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- Already receiving standard MOUD (buprenorphine or methadone)
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- Outpatient setting
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- Three sites
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**Intervention:**
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- Semaglutide vs. placebo
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- 12-week treatment period
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- Added to existing MOUD background therapy
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**Primary Endpoint:**
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- Opioid abstinence (confirmed by urine drug screens + self-report)
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## Scientific Rationale
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**Preclinical Evidence:**
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- Rodent models show GLP-1 receptor agonists reduce opioid self-administration
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- Mechanism: GLP-1 receptors in ventral tegmental area modulate dopamine reward circuits
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**Clinical Evidence (pre-trial):**
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- Residential OUD population studies show decreased craving measures
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- Qeadan 2025 real-world data: 40% lower opioid overdose rate in GLP-1 RA users
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- No completed controlled trials in outpatient OUD as of protocol publication
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## Safety Considerations
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**Documented Concerns:**
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- Pancreatic cysts and cancer risk
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- Hypoglycemia
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- Muscle cramps
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- Cognitive slowing
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- Drug interactions with buprenorphine/methadone
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**Population Risk:**
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- Treatment-refractory patients represent high-difficulty population
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- Higher baseline risk for adverse outcomes
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## Significance
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**Why This Trial Matters:**
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- Only active well-powered Phase 2 RCT for GLP-1 in OUD
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- Tests whether real-world observational signal (Qeadan 2025) holds under controlled conditions
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- Specifically targets treatment-refractory population (not achieving abstinence with standard MOUD)
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- Will determine if GLP-1 reward circuit mechanism extends beyond food/alcohol to opioids
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**Expected Timeline:**
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- Results anticipated 2026-2027
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- Positive result would elevate GLP-1 OUD mechanism claim from "experimental" to "likely" confidence
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- Null result would suggest mechanism specificity to food/alcohol reward circuits
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## Timeline
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- **2025** — Protocol published in Addiction Science & Clinical Practice
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- **2025-2026** — Trial enrollment and treatment ongoing
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- **2026-2027** — Results expected (monitoring required)
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## Research Context
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Patricia Grigson is a leading addiction neuroscience researcher at Penn State College of Medicine. This NIH-funded trial represents the first rigorous controlled test of GLP-1 receptor agonists for opioid use disorder in an outpatient population already receiving medication-assisted treatment.
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## Monitoring Notes
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**Status:** Protocol-only publication. No results available as of April 2026.
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**Action Required:** Monitor for results publication Q3/Q4 2026 or early 2027. Results will directly inform whether the GLP-1 reward circuit mechanism claim can extend to opioids with "likely" confidence.
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**KB Impact:** When results publish, this becomes a primary source for evaluating the OUD extension of the existing claim "glp1-receptor-agonists-address-substance-use-disorders-through-mesolimbic-dopamine-modulation"
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@ -7,9 +7,12 @@ date: 2025
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domain: health
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secondary_domains: []
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format: peer-reviewed study
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status: unprocessed
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status: processed
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processed_by: vida
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processed_date: 2026-04-24
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priority: medium
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tags: [glp-1, semaglutide, opioid-use-disorder, OUD, addiction, clinical-trial, Phase-2, VTA-dopamine, reward-circuit, NCT06548490]
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extraction_model: "anthropic/claude-sonnet-4.5"
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---
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## Content
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