Bipolar Disorder Clinical Trial
— BESTOfficial title:
Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder
Verified date | April 2015 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators' hypothesis is that add-on varenicline will be effective (versus placebo)
in initiating abstinence from smoking in subjects with stable, euthymic bipolar disorder who
are motivated to quit smoking within four weeks. This primary outcome will be assessed from
randomization to 12 weeks or end of the treatment phase of the study. Secondarily, the
investigators also hypothesize that varenicline will prevent relapse in the subsequent
12-weeks follow-up non-treatment phase. Furthermore, the investigators plan to test the
effectiveness of varenicline in reducing nicotine withdrawal symptoms or urges to smoke, as
well as its safety for use in stable bipolar patients when used as an add-on treatment for
smoking cessation.
The investigators plan to test these hypotheses by conducting a randomized,
placebo-controlled add-on treatment trial of Chantix with 60 recruited subjects diagnosed
with DSM-IV bipolar disorder for a period of three months. The investigators will follow-up
with them three months later to evaluate extended abstinence.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Subject inclusion criteria 1. DSM IV-TR Bipolar I or II or Bipolar NOS Disorder 2. Ability to provide written informed consent 3. Male or Female patients, all races, ages 18 to 65 years inclusive 4. Negative serum pregnancy test for females of child-bearing potential. Patients must agree to one of the following birth control methods: an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an injectable contraceptive (e.g., Depo Provera) for at least 1 month prior to entering the study and will continue its use through at least 30 days after the last dose of study medication or a barrier method of contraception, e.g., condom and/or diaphragm with spermicide while participating in the study through at least 30 days after the last dose of study medication or abstinence. 5. MADRS total scores = 8 (past 4 weeks) (suicidal item, score = 1, past 4 weeks). 6. Y-MRS scores = 8 (past 4 weeks) irritability, speech content, disruptive, or aggressive behavior items score = 3, past 4 weeks) 7. Stable doses of primary bipolar maintenance medication for at least 8 weeks prior to randomization 8. No psychiatric hospitalization or Emergency Room Visits for psychiatric issues in the 6-month period prior to randomization 9. No suicidal attempts or behavior history past 6 months 10. No aggressive or violent acts or behavior by history past 6 months Subject exclusion criteria 1. Uncontrolled seizure disorders and other neurological disorders including Huntington's Chorea, Multiple Sclerosis, Cerebral Palsy, and stroke (cerebrovascular accident, CVA). 2. Current alcohol or other substance abuse or dependence within the last 3 months (caffeine will be permitted, nicotine dependence is part of inclusion criteria), including a case-by-case evaluation of those who meet remission criteria and who are on long-term substance abuse and/or alcohol abuse treatment. 3. Female patients who are pregnant, lactating or likely to become pregnant in next 6 months 4. Uncontrolled diabetes mellitus, asthma, seizure disorder, uncontrolled hypertension, (uncontrolled hypertension is defined as Systolic BP > 150 mm or Hg or diastolic BP > 95 mm or Hg on 2 consecutive BP readings 15 minutes apart at the time of screening) or unstable medical illness. Moderate to severe renal disease - moderate renal failure is defined as serum Creatinine >1.3 mg/dl in women and > 1.5 mg/dl in men, at the time of screening. 5. Severe dizziness or fainting due to orthostatic blood pressure changes 6. Known hypersensitivity to varenicline 7. Current use of cimetidine 8. Current treatment with heparin, warfarin, or lidocaine 9. Comorbid psychiatric condition diagnosed within the last three months. Subject smoking inclusion criteria 1. Score of 7 or greater on the Contemplation Ladder, and willing to pick a target quit date within the next 4 weeks. 2. Smoke > 10 cigarettes per day. 3. Expired breath CO level > 10 ppm at screening and randomization. 4. No use of smoking cessation medication and/or behavioral treatment for smoking cessation in the past three months. 5. No current use of any nicotine replacement treatment. 6. Not using any tobacco products other than cigarettes. 7. No current treatment for smoking cessation (hypnosis, acupuncture, others). 8. No current use or past treatment failure with varenicline. 9. No current treatment with bupropion for smoking cessation. |
Country | Name | City | State |
---|---|---|---|
United States | Dubois Regional Medical Center | DuBois | Pennsylvania |
United States | Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
K.N. Roy Chengappa | National Institute of Mental Health (NIMH), Pfizer |
United States,
Chengappa KN, Perkins KA, Brar JS, Schlicht PJ, Turkin SR, Hetrick ML, Levine MD, George TP. Varenicline for smoking cessation in bipolar disorder: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014 Jul;75(7):765-72. doi: 10.408 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks | To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence at 12 weeks | 12 weeks | |
Primary | 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks | To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence | 24 weeks | |
Secondary | Participants Experiencing Neuropsychiatric Events | Evaluate the safety of varenicline in treatment-emergent hypomania, mania, mixed or depressed episodes or being associated suicidal or aggressive behavior or psychotic symptoms when used as adjunctive treatment in participants with bipolar disorder. | 24 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT02855762 -
Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder
|
N/A | |
Recruiting |
NCT05915013 -
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
|
Phase 1 | |
Recruiting |
NCT05206747 -
Ottawa Sunglasses at Night for Mania Study
|
N/A | |
Completed |
NCT02513654 -
Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects
|
Phase 1 | |
Recruiting |
NCT06313918 -
Exercise Therapy in Mental Disorders-study
|
N/A | |
Completed |
NCT02304432 -
Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine
|
Early Phase 1 | |
Recruiting |
NCT06197048 -
Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder
|
N/A | |
Completed |
NCT03497663 -
VIA Family - Family Based Early Intervention Versus Treatment as Usual
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Completed |
NCT02212041 -
Electronic Cigarettes in Smokers With Mental Illness
|
N/A | |
Recruiting |
NCT05030272 -
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
|
N/A | |
Recruiting |
NCT04298450 -
ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention
|
N/A | |
Active, not recruiting |
NCT03641300 -
Efficacy of Convulsive Therapies for Bipolar Depression
|
N/A | |
Not yet recruiting |
NCT04432116 -
Time and Virtual Reality in Schizophrenia and Bipolar Disorder
|
N/A | |
Terminated |
NCT02909504 -
Gao NARASD Lithium Study
|
Phase 4 | |
Terminated |
NCT02893371 -
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
|
||
Completed |
NCT02970721 -
Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
|
||
Recruiting |
NCT02481245 -
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
|
Phase 2 | |
Recruiting |
NCT03088657 -
Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
|