diff --git a/entities/health/nct06548490-semaglutide-oud-phase2.md b/entities/health/nct06548490-semaglutide-oud-phase2.md new file mode 100644 index 000000000..b748893ee --- /dev/null +++ b/entities/health/nct06548490-semaglutide-oud-phase2.md @@ -0,0 +1,81 @@ +# NCT06548490: Semaglutide for OUD Phase 2 RCT + +**Type:** Clinical Trial Protocol +**Status:** Active (ongoing, no results) +**Phase:** 2 +**Design:** Randomized, double-blind, placebo-controlled +**Registration:** NCT06548490 +**Principal Investigator:** Patricia S. Grigson, Penn State +**Funding:** NIH +**Publication:** Addiction Science & Clinical Practice, 2025 + +## Trial Design + +**Population:** +- 200 participants with treatment-refractory opioid use disorder +- Already receiving standard MOUD (buprenorphine or methadone) +- Outpatient setting +- Three sites + +**Intervention:** +- Semaglutide vs. placebo +- 12-week treatment period +- Added to existing MOUD background therapy + +**Primary Endpoint:** +- Opioid abstinence (confirmed by urine drug screens + self-report) + +## Scientific Rationale + +**Preclinical Evidence:** +- Rodent models show GLP-1 receptor agonists reduce opioid self-administration +- Mechanism: GLP-1 receptors in ventral tegmental area modulate dopamine reward circuits + +**Clinical Evidence (pre-trial):** +- Residential OUD population studies show decreased craving measures +- Qeadan 2025 real-world data: 40% lower opioid overdose rate in GLP-1 RA users +- No completed controlled trials in outpatient OUD as of protocol publication + +## Safety Considerations + +**Documented Concerns:** +- Pancreatic cysts and cancer risk +- Hypoglycemia +- Muscle cramps +- Cognitive slowing +- Drug interactions with buprenorphine/methadone + +**Population Risk:** +- Treatment-refractory patients represent high-difficulty population +- Higher baseline risk for adverse outcomes + +## Significance + +**Why This Trial Matters:** +- Only active well-powered Phase 2 RCT for GLP-1 in OUD +- Tests whether real-world observational signal (Qeadan 2025) holds under controlled conditions +- Specifically targets treatment-refractory population (not achieving abstinence with standard MOUD) +- Will determine if GLP-1 reward circuit mechanism extends beyond food/alcohol to opioids + +**Expected Timeline:** +- Results anticipated 2026-2027 +- Positive result would elevate GLP-1 OUD mechanism claim from "experimental" to "likely" confidence +- Null result would suggest mechanism specificity to food/alcohol reward circuits + +## Timeline + +- **2025** — Protocol published in Addiction Science & Clinical Practice +- **2025-2026** — Trial enrollment and treatment ongoing +- **2026-2027** — Results expected (monitoring required) + +## Research Context + +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. + +## Monitoring Notes + +**Status:** Protocol-only publication. No results available as of April 2026. + +**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. + +**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" \ No newline at end of file diff --git a/inbox/queue/2026-04-24-glp1-oud-rct-protocol-nct06548490-penn-state.md b/inbox/archive/health/2026-04-24-glp1-oud-rct-protocol-nct06548490-penn-state.md similarity index 97% rename from inbox/queue/2026-04-24-glp1-oud-rct-protocol-nct06548490-penn-state.md rename to inbox/archive/health/2026-04-24-glp1-oud-rct-protocol-nct06548490-penn-state.md index eded01845..31c30e878 100644 --- a/inbox/queue/2026-04-24-glp1-oud-rct-protocol-nct06548490-penn-state.md +++ b/inbox/archive/health/2026-04-24-glp1-oud-rct-protocol-nct06548490-penn-state.md @@ -7,9 +7,12 @@ date: 2025 domain: health secondary_domains: [] format: peer-reviewed study -status: unprocessed +status: processed +processed_by: vida +processed_date: 2026-04-24 priority: medium tags: [glp-1, semaglutide, opioid-use-disorder, OUD, addiction, clinical-trial, Phase-2, VTA-dopamine, reward-circuit, NCT06548490] +extraction_model: "anthropic/claude-sonnet-4.5" --- ## Content