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NCT00781755
Treating Schizophrenic Smokers: Effects on Craving, Cues and Withdrawal
Phase 4 trial testing varenicline in Tobacco Use Disorder. Withdrawn.
Quick facts
| Lead sponsor | VA Boston Healthcare System |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Sites | 1 location across United States |
Drugs / interventions tested
- varenicline (varenicline) — full drug profile →
- Adaptation of Motivational Interviewing
Conditions studied
- Tobacco Use Disorder — all drugs for Tobacco Use Disorder →
Sponsor
VA Boston Healthcare System
Who can join
Adults 18 to 65, any sex, with Tobacco Use Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a clinical research protocol to study the efficacy of combined varenicline (Chantix) and motivational interviewing (MI) for smoking cessation in a sample of smokers who have been diagnosed with schizophrenia or schizoaffective disorder. The study is a double-blind, randomized, controlled, subacute treatment trial of MI plus varenicline (VAR-MI) versus MI plus placebo (PLA-MI). The pharmaceutical treatment will utilize Chantix at a dose of 1 mg/day for a period of two weeks. The primary goal is to determine if VAR-MI decreases baseline behavioral measures of urge and withdrawal and reduces baseline rates of cigarette consumption. The primary efficacy measures of VAR-MI vs. PLA-MI treatment are: Minnesota Nicotine Withdrawal Scale, Questionnaire for Smoking Urge-brief, number of cigarettes smoked per day in the previous week, CO levels, and Brief Psychiatric Rating Scale and Positive And Negative Symptom Scale scores on the last day of the study. Other primary outcome measures are to determine the effects of VAR-MI and PLA-MI on smoking cue-induced urges in tobacco cue reactivity sessions and reward responsiveness as assessed by a computerized task.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00781755
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of varenicline
Trials testing the same drug.
- NCT07145866 — Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study) · Phase 4 · not yet recruiting
- NCT02854800 — Smoking Cessation & Opioid Dependence Treatment Integration · Phase 2, PHASE3 · completed
- NCT01771627 — Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers · NA · completed
- NCT01290445 — Varenicline Pregnancy Cohort Study · completed
Other recruiting trials for Tobacco Use Disorder
Currently open trials in the same condition.
- NCT07466875 — Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients · NA · recruiting
- NCT06678672 — Contingency Management for Veteran Smokers Undergoing Major Elective Surgery · NA · recruiting
- NCT06006143 — Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2 · Phase 2 · active not recruiting
- NCT06883162 — Cannabis-Tobacco Co-Use Treatment Study · Phase 3 · recruiting
- NCT06798324 — tDCS Plus Varenicline for Smoking Cessation · Phase 4 · recruiting
Other VA Boston Healthcare System trials
Trials by the same sponsor.
- NCT06389981 — Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Ca · NA · completed
- NCT06792877 — Mindfulness for Cognition in Early-stage Alzheimer's Disease · NA · recruiting
- NCT05663151 — Mechanisms Underlying the Efficacy of Prolonged Exposure · NA · recruiting
- NCT04723745 — Translational Research Center for TBI and Stress Disorders: Virtual Assessment of Deployment Trauma and Rehabilitation · unknown
- NCT03808727 — Massed Cognitive Processing Therapy for Combat-related PTSD · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00781755 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by VA Boston Healthcare System
- Last refreshed: 4 June 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00781755.
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