TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03092193

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Naproxen
Description: 20 phenotyped for CYP2C9 and CYP2C19 (by PCR) and for the pharmacokinetics of naproxen, saliva samples will be collected of these patients at different times after ingestion of a tablet of naproxen (500mg) (before, 0,25; 0,5; 0,75; 1; 1,5; 2; 3; 4; 5; 6; 8; 11; 24; 48; 72 e 96 hours after ingestion).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Naproxen-esomeprazole
Description: 20 phenotyped for CYP2C9 and CYP2C19 (by PCR) and for the pharmacokinetics of naproxen-esomeprazole, saliva samples will be collected of these patients at different times after ingestion of a tablet of naproxen-esomeprazole (500mg+20mg) (after one month of the first collection) (before, 0,25; 0,5; 0,75; 1; 1,5; 2; 3; 4; 5; 6; 8; 11; 24; 48; 72 e 96 hours after ingestion).
Study: NCT01346592

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Trivalent split influenza vaccine (TIV)

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: MF59-adjuvanted trivalent influenza vaccine (aTIV)

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Licensed comparator trivalent split influenza vaccine (comparator TIV)
Study: NCT00773461

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tocilizumab [RoActemra/Actemra]
Description: 8mg/kg iv every 4 weeks for 24 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: iv every 4 weeks for 24 weeks
Study: NCT05040399

Intervention type: OTHER
Group type: OTHER
Intervention: Locking Compression Plates
Description: Plates and screws for sternal fixation

Intervention type: OTHER
Group type: OTHER
Intervention: Sternal Wires
Description: sternal wires used for fixation of sternum
Study: NCT03925064

Intervention type: OTHER
Intervention: myocardial performance index
Description: fetal right ventricular myocardial performance index measured with tissue doppler

Intervention type: OTHER
Intervention: myocardial performance index
Description: fetal right ventricular myocardial performance index measured with tissue doppler
Study: NCT00895856

Intervention type: OTHER
Intervention: Evaluation of the functional capacity
Description: An evaluation (questionnaire) was performed by the Katz Index of individuals in this group, including personal issues (sex and age) and different levels of functional independence for the elderly in their basic activities of daily living (ABVD's) such as: bathe, dress, use the bathroom for withdrawals, transfers perform, has control of the sphincters and the food itself. Subject themselves, if capable of responding to the issues of consistency index, did. The answers were given to the auxiliary nurse responsible for care to residents.
Study: NCT01502280

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-Aminolevulinic acid (ALA)
Description: Following informed consent, within 3 hours prior to surgery, patient will orally ingest \[or be given via Nasogastric (NG), Orogastric (OG), or Gastric tube (G-tube)\] either (1) 5-ALA/Gliolan® mixed with sterile water (20mg/kg)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo - ascorbic acid
Description: Within 3 hours prior to surgery, patient will orally ingest \[or be given via Nasogastric (NG), Orogastric (OG), or Gastric tube (G-tube)\] 1.5 Gm. placebo - ascorbic acid in 50 ml sterile water.
Study: NCT00572897

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine, Melphalan +/- ATG
Description: Conditioning regimen for Allogenic Stem Cell Transplant:~Related Donor Fludarabine days -6 to -2 (30mg/m2 IVPB over 30 minutes daily) Melphalan days -3 to -2 (70mg/m2 IVPB over 30 minutes daily)~Unrelated Donor Fludarabine days -6 to -2 (30mg/m2 IVPB over 30 minutes daily) Melphalan days -3 to -2 (70mg/m2 IVPB over 30 minutes daily) ATG (Thymoglobulin®) days -3 to -1 (0.5 mg/kg IV on day -3 \[given over 6 hours\], and 2 mg/kg on days -2 and -1 \[given over 4 hours\])
Study: NCT03438383

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Bi-PAP
Description: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Sham Bi-PAP
Description: Sham Bi-PAP was created by introducing a hole at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
Study: NCT01047735

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Roux-en-Y Gastric Bypass Surgery
Description: Participants assigned to the Roux-en-Y Gastric Bypass treatment group will undergo a surgical procedure that limit foods intake and causes nutrients malabsorption. The procedure is performed with small incisions or laparoscopically. A small stomach pouch is created, the size of an egg, and the small intestine is connected to the pouch. Some of the stomach and small intestine are consequently bypassed by this anatomic change. Those in this treatment group will begin a gradual diet post surgery and will take life long vitamin supplements.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Laparoscopic Adjustable Gastric Banding
Description: Those assigned to the Laparoscopic Adjustable Gastric Banding study group will undergo a surgical procedure where an adjustable silicone band is placed around the upper stomach to decrease its capacity so that you will feel full sooner. It will assist in weight loss by helping you to limit intake of calories. The band will be placed by using several small incisions and telescopic instruments. A thin tube connects the band to an access port just under the skin that you may be able to feel but you will not be able to see it. This allows the band to be tightened or loosened to decrease or increase your stomach capacity as needed. The surgery will take on average 30-45 minutes.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Lifestyle Weight Loss Intervention
Description: Participants will receive a standard behavior weight control program in an in-person format over a period of 12 months conducted by an experienced team of weight loss counselors. During the initial 6 months of study treatment, will attend weekly in-person individual sessions with a weight loss counselor. During months 7-12, will attend in-person sessions on the 1st and 3rd week of the month and will receive a brief (less than 10 minutes in duration) telephone call on the 2nd and 4th week of the month. Each session will focus on a specific behavioral topic related to weight loss, eating behaviors, or exercise behaviors.
Study: NCT04445844

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pelareorep
Description: Given IV

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Quality-of-Life Assessment
Description: Ancillary studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Questionnaire Administration
Description: Ancillary studies

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Retifanlimab
Description: Given IV
Study: NCT04283409

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Graded activity
Description: Exercise therapy using principles of cognitive behavioral therapy and education

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Motor Control Exercises
Description: Exercise therapy using principles of motor control and motor learning and education
Study: NCT03675893

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Abemaciclib
Description: Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Abemaciclib
Description: Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LY3023414
Description: LY3023414 is a potent selective inhibitor of the class I PI3K isoforms, mTOR, and DNA-PK.
Study: NCT03808922

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DAS181
Description: DAS181 4.5mg nebulized qd x 7 OR 10 days

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo nebulized qd x 7 OR 10 days

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo nebulized qd x 7 OR 10 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DAS181 COVID-19
Description: DAS181 4.5mg nebulized q12h/day x 7 OR 10 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DAS181 OL
Description: DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days \< 40kg
Study: NCT01503177

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: oncolytic measles virus encoding thyroidal sodium iodide symporter
Description: Given intrapleurally

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: single photon emission computed tomography
Description: Correlative studies
Study: NCT03808922

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DAS181 OL
Description: DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days \< 40kg
Study: NCT01503177

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: computed tomography
Description: Correlative studies
Study: NCT04548219

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mirikizumab
Description: Reference and test formulations of mirikizumab administered as a SC injection.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mirikizumab
Description: Reference and test formulations of mirikizumab administered as a SC injection.
Study: NCT00190528

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: neoadjuvant chemotherapy + radical hysterectomy

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: radical hysterectomy
Study: NCT02067598

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: scapular exercise
Study: NCT03675893

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LY3023414
Description: LY3023414 is a potent selective inhibitor of the class I PI3K isoforms, mTOR, and DNA-PK.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Metformin inhibits mitochondrial adenosine-5'-triphosphate (ATP) synthesis, resulting in activation of the AMPK (5' AMP-activated protein kinase) pathway through LKB1, eventually causing inhibition of the mTOR pathway and subsequent reduction in protein synthesis and cellular proliferation.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zotatifin
Description: Zotatifin is a selective eukaryotic initiation factor 4A (eIF4A) inhibitor.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zotatifin
Description: Zotatifin is a selective eukaryotic initiation factor 4A (eIF4A) inhibitor.
Study: NCT04178473

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: total abdominal hysterectomy
Description: total abdominal hysterectomy at time of sacrocolpopexy

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Subtotal abdominal hysterectomy
Description: Subtotal abdominal hysterectomy at time of sacrocolpopexy
Study: NCT04046562

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: PAW
Description: Pain and Weight Treatment plus standard of care

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Pain Education
Description: Pain Education plus standard of care
Study: NCT03768570

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Durvalumab
Description: 1500 mg IV on day 1 of 4 week cycle every 4 weeks for 12 months
Study: NCT04169100

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: We propose to test whether QT prolongation is reversible with moderate doses of prednisone in patients with QT interval greater than 500 msec.
Study: NCT04568993

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Proximal phalangeal level
Description: Injection of methyl prednisone and lidocaine in the tendon sheet at the level of the proximal phalanx

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Volar to the MCP-joint
Description: Injection of methyl prednisone and lidocaine in the tendon sheet volar to the MCP-joint
Study: NCT01093638

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Oral Formulation of Insulin
Description: Oral formulation of insulin fed concomitantly with infant formula

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Oral formulation of placebo fed concomitantly with infant formula
Study: NCT03827837

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SHR-1210
Description: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Study: NCT02006290

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-06412562
Description: single oral split dose 30+20 mg QD

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: tablet, matching placebo, QD
Study: NCT03827837

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Famitinib
Description: a small-molecule multikinase inhibitor
Study: NCT01163266

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vortioxetine
Description: Encapsulated vortioxetine immediate release tablets
Study: NCT04425577

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Transabdominal Ultrasound
Description: Transabdominal Ultrasound
Study: NCT02183376

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 1356

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 1356

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 1356

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 1356
Study: NCT02926170

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rivaroxaban
Description: Rivaroxaban will be started at 20 mg/day. Dose will be adjusted according to Cr Clearance. Cr Clearance 30-49 ml/min will receive 15 mg/day.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: acenocumarol
Description: Doses will be adjusted according to INR
Study: NCT04677686

Intervention type: BEHAVIORAL
Intervention: Bundle of Care
Description: Hair removal with Clipper Glucose Control Preoperative antibiotics Repeat antibiotics after 4 Hours Optimize Body temperature Instrument change for colorectal anastomosis Use of wound protectors Experienced surgeon Preoperative showering
Study: NCT03109041

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: CivaSheet
Description: The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.
Study: NCT01163266

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vortioxetine
Description: Encapsulated vortioxetine immediate release tablets

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Vortioxetine placebo-matching capsules
Study: NCT02765685

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: brace ODRA (PROTEOR company)
Description: Port of the orthosis ODRA during day during 12 months, Complement to their usual care. The subjects will have for instruction to wear the brace a minimum of 6 hours a day, 5 days a week, And to remove it during the rest periods in lengthened position.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Usual care
Description: The patients will benefit only from the coverage proposed usually, by their regular doctor and according to the notices of the medical and paramedical specialists taking care of this pathology (physiotherapists, orthopaedic osteopaths, sports medicine physician, surgeon, rheumatologists, rehabilitative doctors, etc.). In the absence of recommendations on the modalities of coverage of the gonarthrose and in front of diverse clinical habits, the usual said coverage can be at the same time medicinal (anti-inflammatory, painkilling, ...), non-medicinal (physiotherapy, port of an orthosis, ...), even surgical, according to the influencers.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Usual care
Description: The patients will benefit only from the coverage proposed usually, by their regular doctor and according to the notices of the medical and paramedical specialists taking care of this pathology (physiotherapists, orthopaedic osteopaths, sports medicine physician, surgeon, rheumatologists, rehabilitative doctors, etc.). In the absence of recommendations on the modalities of coverage of the gonarthrose and in front of diverse clinical habits, the usual said coverage can be at the same time medicinal (anti-inflammatory, painkilling, ...), non-medicinal (physiotherapy, port of an orthosis, ...), even surgical, according to the influencers.
Study: NCT04620655

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RD13-01 cell infusion
Description: Universal CAR-T cells targeting CD7
Study: NCT04132427

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: vancomycin, magnesium citrate, microbiota
Description: 10 days of oral vancomycin, then 1 day of oral magnesium citrate, , then 4 days of high-dose oral microbiota, followed by 12 weeks of low-dose oral microbiota

Intervention type: COMBINATION_PRODUCT
Group type: PLACEBO_COMPARATOR
Intervention: placebo vancomycin, real magnesium citrate, placebo microbiota
Description: 10 days of oral placebo vancomycin, then 1 day of oral real magnesium citrate, , then 4 days of high-dose oral placebo microbiota, followed by 12 weeks of low-dose oral placebo microbiota
Study: NCT02343250

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cilnidipine/Valsartan
Description: Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cilnidipine+Valsartan
Description: Cinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cilnidipine/Valsartan
Description: Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cilnidipine+Valsartan
Description: Cinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle
Study: NCT00609154

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: glucagon like peptide-1
Description: GLP-1 1 pmole/kg/min

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: glucagon like peptide-1
Description: GLP-1 1 pmole/kg/min

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: glucose control
Description: glucose without GLP-1

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: glucose control
Description: glucose without GLP-1
Study: NCT03388008

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Belatacept
Description: Belatacept will be dosed at 10 mg/kg of actual body weight on days 0, 7, 14, 28, 56, and 84 then at 5 mg/kg on day 112 and every 28 days through day 364 (i.e., on days 140, 168, 196, 224, 252, 280, 308, 336, and 364)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tacrolimus
Description: Tacrolimus will be dosed enterally or sublingually within 48 hours of transplantation and the dose will be adjusted to target a trough blood level of 8-15 ng/ml

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ATG
Description: Anti-thymocyte globulin will be dosed intravenously at 3 mg/kg divided into 3 daily doses starting on day 0 after transplantation

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: ATG
Description: Anti-thymocyte globulin will be dosed intravenously at 3 mg/kg divided into 3 daily doses starting on day 0 after transplantation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mycophenolate Mofetil
Description: Mycophenolate mofetil will be dosed at 1000 mg twice daily (or if the enteric coated formulation is used, this will be dosed at 720 mg twice daily. In the standard of care arm, mycophenolate mofetil will be initiated on day 0 after transplantation, whereas in the belatacept-based immunosuppression arm, mycophenolate mofetil will be initiated on day 90 after transplantation

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Mycophenolate Mofetil
Description: Mycophenolate mofetil will be dosed at 1000 mg twice daily (or if the enteric coated formulation is used, this will be dosed at 720 mg twice daily. In the standard of care arm, mycophenolate mofetil will be initiated on day 0 after transplantation, whereas in the belatacept-based immunosuppression arm, mycophenolate mofetil will be initiated on day 90 after transplantation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methylprednisolone
Description: Methylprednisolone 500 mg will be given intravenously before perfusion of the allograft during the transplant procedure, then methylprednisolone 0.5 mg/kg will be given intravenously twice daily for 6 total doses

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methylprednisolone
Description: Methylprednisolone 500 mg will be given intravenously before perfusion of the allograft during the transplant procedure, then methylprednisolone 0.5 mg/kg will be given intravenously twice daily for 6 total doses

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Prednisone will be dosed at 0.5 mg/kg orally daily through day 14, then 0.2 mg/kg orally daily through day 30, then 0.1 mg/kg daily through day 180, then 5 mg daily through day 365

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Prednisone
Description: Prednisone will be dosed at 0.5 mg/kg orally daily through day 14, then 0.2 mg/kg orally daily through day 30, then 0.1 mg/kg daily through day 180, then 5 mg daily through day 365
Study: NCT03375749

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Standing desk intervention
Description: Standing desk converter

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Waitlist control
Description: Control
Study: NCT00000317

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Risperidone
Description: Risperidone (4mg/day)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Relapse prevention counseling
Description: Modified manual guided relapse prevention counseling. Weekly 20 minute sessions consisting of cognitive behavioral skills. Both arms will receive this intervention.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Relapse prevention counseling
Description: Modified manual guided relapse prevention counseling. Weekly 20 minute sessions consisting of cognitive behavioral skills. Both arms will receive this intervention.
Study: NCT00702793

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Varenicline
Description: Varenicline 0.5 mg/d for days 1 to 3, 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily through week 12. Administration of twice daily dosing should be at least 8 hours apart.