A Phase 4 interventional study of Varenicline in Bipolar Disorder, Schizophrenia and Schizoaffective Disorder, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by University of California, San Diego · Phase 4, Interventional, and Treatment
Approximately 60 chronic smokers with bipolar disorder, schizophrenia or schizoaffective disorder who are motivated to try to quit smoking will be randomized to receive smoking cessation treatment with the FDA-approved medication, varenicline, delivered either a) at its standard dose and titration schedule (half of the participants) versus b) at a lower dose and slower titration schedule (the other half), for 12 weeks. All smokers will choose a target quit date sometime between 8 to 35 days after starting the medication. All participants will receive ten 30-minute sessions of a behavioral treatment called Acceptance and Commitment Therapy (ACT). Participants will be followed for an additional 12 weeks off study medication. The major endpoint is the feasibility of combining ACT with the different dosing strategies. Investigators will also conduct a blood test that measures the breakdown of nicotine in the body to explore whether that measure influences treatment response and side effects.
This pilot feasibility trial is a Phase IV, 12-week, single center, randomized, double blind, parallel group comparison of low (0.5 mg twice daily with slower titration over one full week) versus standard dose (1.0 mg twice daily with standard titration) varenicline in individuals with DSM-V Bipolar Disorder (BD) or Schizophrenia Spectrum Disorders (SSD) with a 12-week, post-treatment follow-up. The 16 visits after screening (Weeks 0-24) include 11 in-person (with medications dispensed at weeks 0, 2, 4, 6, 8 and 10] and 5 via telephone. Plasma will be obtained at baseline to measure participants' Nicotine Metabolite Ratio (NMR) and to identify slow versus normal nicotine metabolisers. A flexible quit date (between days 8-35) will be employed allowing varenicline preloading to occur prior to the Target Quit Date. Ten sessions of Acceptance \& Commitment Therapy (ACT) for smoking cessation will be delivered by trained counselors.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 39 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.5 mg twice daily with 0.5 mg daily titration over one full week
Drug: Varenicline
1.0 mg twice daily with standard titration
Drug: Varenicline
The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.
Also known as: Acceptance and Commitment Therapy
Feasibility of Combining ACT With 2 Different Varenicline-assisted Quitting Strategies
Demand for participating (# of participants recruited per month); practicality of study procedures (% participants completing study procedures); acceptability of study procedures (% participants adhering to making a quit attempt within the quit window)
Time frame: Through completion of study, an average of 2 years
Nicotine Metabolite Ratio (NMR) Exploratory Aim
The nicotine metabolite ratio (NMR) as measured by the ratio of 3'-hydroxycotinine (the breakdown product of cotinine) divided by the concentration of cotinine (the breakdown product of nicotine) in a smoker's serum is a biomarker of nicotine clearance. Other researchers have found that a person's NMR might influence one's response to certain smoking cessation medications. The NMR was measured in serum using electrospray ionization liquid chromatography tandem mass spectrometry technology.
Time frame: Through completion of study, an average of 2 years
| Milestone | Low Dose Varenicline | Standard Dose Varenicline |
|---|---|---|
| Started | 14 | 14 |
| Completed | 9 | 12 |
| Not completed | 5 | 2 |
Demand for participating (# of participants recruited per month); practicality of study procedures (% participants completing study procedures); acceptability of study procedures (% participants adhering to making a quit attempt within the quit window)
| Participants | Low Dose Varenicline | Standard Dose Varenicline |
|---|---|---|
| Demand For Participating | 1 | 1 |
| Practicality of Study Procedures | 9 | 12 |
| Acceptability of Study Procedures | 13 | 12 |
The nicotine metabolite ratio (NMR) as measured by the ratio of 3'-hydroxycotinine (the breakdown product of cotinine) divided by the concentration of cotinine (the breakdown product of nicotine) in a smoker's serum is a biomarker of nicotine clearance. Other researchers have found that a person's NMR might influence one's response to certain smoking cessation medications. The NMR was measured in serum using electrospray ionization liquid chromatography tandem mass spectrometry technology.
| ratio of molar concentrations | Smokers With Serious Mental Illness |
|---|---|
| Nicotine Metabolite Ratio (NMR) Exploratory Aim | 1.20 ± 0.75 |
Collected over Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Dose Varenicline | 0/14 (0%) | 0/14 (0%) | 13/14 (92.9%) |
| Standard Dose Varenicline | 0/14 (0%) | 1/14 (7.1%) | 12/14 (85.7%) |
| Event | Low Dose Varenicline | Standard Dose Varenicline |
|---|---|---|
| DepressionPsychiatric disorders | 0/14 | 1/14 |
| Event | Low Dose Varenicline | Standard Dose Varenicline |
|---|---|---|
| AnxietyPsychiatric disorders | 7/14 | 2/14 |
| DysgeusiaGeneral disorders | 7/14 | 6/14 |
| Sleep DisturbancesPsychiatric disorders | 5/14 | 4/14 |
| DepressionPsychiatric disorders | 3/14 | 4/14 |
| NauseaGastrointestinal disorders | 4/14 | 1/14 |
| AgitationPsychiatric disorders | 3/14 | 1/14 |
| HeadacheNervous system disorders | 3/14 | 2/14 |
| HostilityPsychiatric disorders | 0/14 | 2/14 |
| HeartburnGastrointestinal disorders | 2/14 | 0/14 |
| VertigoNervous system disorders | 0/14 | 2/14 |
| Age, Categorical(Participants) | Low Dose Varenicline | Standard Dose Varenicline | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 14 | 27 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Low Dose Varenicline | Standard Dose Varenicline | Total |
|---|---|---|---|
| Mean | 50 ± 9.8 | 45.6 ± 11.6 | 47.8 ± 10.8 |
| Sex: Female, Male(Participants) | Low Dose Varenicline | Standard Dose Varenicline | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 8 | 7 | 15 |
| Ethnicity (NIH/OMB)(Participants) | Low Dose Varenicline | Standard Dose Varenicline | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 13 | 13 | 26 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Low Dose Varenicline | Standard Dose Varenicline | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 4 | 8 |
| White | 8 | 6 | 14 |
| More than one race | 1 | 3 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Low Dose Varenicline | Standard Dose Varenicline | Total |
|---|---|---|---|
| United States | 14 | 14 | 28 |
| Diagnosis: Bipolar Disorder (BD) or Schizophrenia Spectrum Disorder (SSD)(Participants) | Low Dose Varenicline | Standard Dose Varenicline | Total |
|---|---|---|---|
| BD | 7 | 8 | 15 |
| SSD | 7 | 6 | 13 |
| Cigarettes Per Day(Cigarettes) | Low Dose Varenicline | Standard Dose Varenicline | Total |
|---|---|---|---|
| Mean | 14.5 ± 3.3 | 25.2 ± 11 | 19.8 ± 9.7 |
4 further baseline measures are reported on the registry.
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University of California, San Diego