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124 Mechanisms of Action

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|||||||||| Trial completion: Re-Entry MTC for Offenders With MICA Disorders (clinicaltrials.gov) - Aug 28, 2013
P=N/A, N=610, Completed, Sponsor: National Development and Research Institutes, Inc.
Active, not recruiting --> Completed

|||||||||| Enrollment closed: The "Prediction of Alcohol Withdrawal Severity Scale" (PAWSS) (clinicaltrials.gov) - Aug 26, 2013
P=N/A, N=409, Active, not recruiting, Sponsor: Stanford University
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  Chantix (varenicline) / Pfizer
Biomarker, Enrollment closed:  Pharmacogenetics of Nicotine Addiction Treatment (clinicaltrials.gov) -  Aug 26, 2013
P3, N=1246, Active, not recruiting,  Sponsor: University of Pennsylvania
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting

||||||||||  progesterone / Generic mfg.
Trial completion:  Progesterone for Postpartum Cocaine Relapse (clinicaltrials.gov) -  Aug 25, 2013
P=N/A, N=50, Completed,  Sponsor: Yale University
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

||||||||||  gemfibrozil / Generic mfg.
Enrollment change:  Initial Screening of Gemfibrozil as a Novel Treatment for Tobacco Addiction (clinicaltrials.gov) -  Aug 20, 2013
P2, N=40, Recruiting,  Sponsor: Centre for Addiction and Mental Health
Active, not recruiting --> Completed N=60 --> 40

|||||||||| Enrollment open: Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^ (clinicaltrials.gov) - Aug 20, 2013
P2, N=70, Recruiting, Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
N=60 --> 40 Suspended --> Recruiting

|||||||||| Enrollment change: AAT-2: Tobacco Approach Avoidance Training for Adolescent Smokers-2 (clinicaltrials.gov) - Aug 18, 2013
P2, N=66, Completed, Sponsor: Yale University
Suspended --> Recruiting N=30 --> 66

|||||||||| New P4 trial: e-Cigarettes Versus NRT Gum for Smoking Cessation (clinicaltrials.gov) - Aug 18, 2013
P4, N=10, Terminated, Sponsor: Creighton University

||||||||||  methamphetamine / Generic mfg.
Enrollment closed:  STAR: Study Targeting Affect Regulation (clinicaltrials.gov) -  Aug 18, 2013
P1/2, N=56, Active, not recruiting,  Sponsor: University of California, San Francisco
N=30 --> 66 Recruiting --> Active, not recruiting

|||||||||| Trial completion, Journal: AAT-1: Tobacco Approach Avoidance Training for Adolescent Smokers-1 (clinicaltrials.gov) - Aug 18, 2013
P2, N=40, Completed, Sponsor: Yale University
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

|||||||||| Enrollment change: Cognitive Training for Nicotine Dependence (clinicaltrials.gov) - Aug 14, 2013
P=N/A, N=200, Recruiting, Sponsor: University of Pennsylvania
Active, not recruiting --> Completed N=340 --> 200

|||||||||| Trial completion: Primary Care Physicians' Use of Stop-Smoking Plans to Help Patients Who Are Smokers (clinicaltrials.gov) - Aug 14, 2013
P=N/A, N=344, Completed, Sponsor: Kaiser Permanente
N=340 --> 200 Active, not recruiting --> Completed

|||||||||| Enrollment open: Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.) (clinicaltrials.gov) - Aug 12, 2013
P=N/A, N=100, Recruiting, Sponsor: New York Methodist Hospital
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Enrollment closed: iQS: A Randomized Trial of Internet Access to Nicotine Patches (clinicaltrials.gov) - Aug 12, 2013
P=N/A, N=2475, Active, not recruiting, Sponsor: University of Michigan
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting

||||||||||  buprenorphine/naloxone sublingual film / Generic mfg., buprenorphine sublingual tablets / Generic mfg.
Trial initiation date:  Study of the Treatment of Experimental Pain in Opioid Dependent Persons on Methadone or Buprenorphine Maintenance (clinicaltrials.gov) -  Aug 8, 2013
P1, N=100, Recruiting,  Sponsor: Johns Hopkins University
Recruiting --> Active, not recruiting Initiation date: May 2013 --> Aug 2013

||||||||||  buprenorphine/naloxone sublingual film / Generic mfg., buprenorphine sublingual tablets / Generic mfg.
Enrollment open:  Study of the Treatment of Experimental Pain in Opioid Dependent Persons on Methadone or Buprenorphine Maintenance (clinicaltrials.gov) -  Aug 8, 2013
P1, N=100, Recruiting,  Sponsor: Johns Hopkins University
Initiation date: May 2013 --> Aug 2013 Not yet recruiting --> Recruiting

|||||||||| Enrollment closed, Surgery: Decision Aid for Cigarette Smokers Undergoing Surgery (clinicaltrials.gov) - Aug 6, 2013
P3, N=170, Active, not recruiting, Sponsor: Mayo Clinic
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting

||||||||||  bupropion / Generic mfg.
Trial completion:  Framing Messages for Smoking Cessation With Bupropion - 6 (clinicaltrials.gov) -  Aug 6, 2013
P=N/A, N=252, Completed,  Sponsor: Yale University
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

||||||||||  Chantix (varenicline) / Pfizer
Enrollment change:  Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking (clinicaltrials.gov) -  Aug 4, 2013
P=N/A, N=315, Completed,  Sponsor: Butler Hospital
Active, not recruiting --> Completed N=602 --> 315

||||||||||  Chantix (varenicline) / Pfizer
Trial completion:  Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking (clinicaltrials.gov) -  Aug 4, 2013
P=N/A, N=315, Completed,  Sponsor: Butler Hospital
N=602 --> 315 Active, not recruiting --> Completed

|||||||||| Trial completion: Phase II A Trial of Curcumin Among Patients With Prevalent Subclinical Neoplastic Lesions (Aberrant Crypt Foci) (clinicaltrials.gov) - Jul 31, 2013
P2, N=48, Completed, Sponsor: National Cancer Institute (NCI)
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| New P2 trial: Clinical Efficacy and Serum Proteomic Profiling of Suan-Zao-Ren Tang for Sleep Disturbance During Methadone Maintenance (clinicaltrials.gov) - Jul 30, 2013
P2, N=90, Completed, Sponsor: China Medical University, Taiwan

||||||||||  emricasan (IDN 6556) / Amerimmune
New P2 trial:  Study of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Steroid Therapy (clinicaltrials.gov) -  Jul 29, 2013
P2, N=60, Recruiting,  Sponsor: Conatus Pharmaceuticals Inc.

|||||||||| Trial completion: Cognitive Stimulation (clinicaltrials.gov) - Jul 29, 2013
P2, N=134, Completed, Sponsor: Johns Hopkins University
Active, not recruiting --> Completed Recruiting --> Completed

|||||||||| Trial completion: VIPS: Voucher-Based Incentives in a Prevention Setting (clinicaltrials.gov) - Jul 29, 2013
P2/3, N=131, Completed, Sponsor: Friends Research Institute, Inc.
Recruiting --> Completed Recruiting --> Completed

|||||||||| New P2 trial: Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders (clinicaltrials.gov) - Jul 28, 2013
P2, N=40, Recruiting, Sponsor: San Diego State University

||||||||||  Bunavail (buprenorphine/naloxone transmucosal) / Collegium Pharma
Enrollment change:  An Open Label Study To Assess The Safety And Tolerability Of BEMA (clinicaltrials.gov) -  Jul 25, 2013
P2, N=249, Completed,  Sponsor: BioDelivery Sciences International
Recruiting --> Completed N=400 --> 249

|||||||||| Enrollment change: Contingency Management for Cocaine Dependence: Cash Versus Vouchers (clinicaltrials.gov) - Jul 25, 2013
P=N/A, N=352, Completed, Sponsor: Treatment Research Institute
N=400 --> 249 N=250 --> 352

||||||||||  Bunavail (buprenorphine/naloxone transmucosal) / Collegium Pharma
Trial completion:  An Open Label Study To Assess The Safety And Tolerability Of BEMA (clinicaltrials.gov) -  Jul 25, 2013
P2, N=249, Completed,  Sponsor: BioDelivery Sciences International
N=250 --> 352 Recruiting --> Completed

|||||||||| Trial completion: Contingency Management for Cocaine Dependence: Cash Versus Vouchers (clinicaltrials.gov) - Jul 25, 2013
P=N/A, N=352, Completed, Sponsor: Treatment Research Institute
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  piracetam / Generic mfg.
Trial withdrawal:  Piracetam for Treatment of Cocaine Addiction, Phase II - 4 (clinicaltrials.gov) -  Jul 24, 2013
P2, N=0, Withdrawn,  Sponsor: University of Pennsylvania
Active, not recruiting --> Completed Completed --> Withdrawn

||||||||||  Twinrix (inactivated hepatitis A and recombinant hepatitis B) / GSK, Engerix-B (hepatitis B vaccine recombinant) / GSK
Enrollment change, Adherence:  UFO VAX: A Randomized Trial of Vaccine Adherence in Young Injection Drug Users (clinicaltrials.gov) -  Jul 24, 2013
P=N/A, N=546, Completed,  Sponsor: University of California, San Francisco
Completed --> Withdrawn N=167 --> 546

||||||||||  amphetamine/dextroamphetamine immediate release tablet / Generic mfg., topiramate / Generic mfg.
Trial initiation date:  TACT2: Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence (clinicaltrials.gov) -  Jul 23, 2013
P2/3, N=176, Recruiting,  Sponsor: New York State Psychiatric Institute
N=167 --> 546 Initiation date: Apr 2013 --> Jul 2013

||||||||||  Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
New P3 trial:  CHOICES: Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study (clinicaltrials.gov) -  Jul 23, 2013
P3, N=50, Not yet recruiting,  Sponsor: Oregon Health and Science University

||||||||||  amphetamine/dextroamphetamine immediate release tablet / Generic mfg., topiramate / Generic mfg.
Enrollment open:  TACT2: Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence (clinicaltrials.gov) -  Jul 23, 2013
P2/3, N=176, Recruiting,  Sponsor: New York State Psychiatric Institute
Initiation date: Apr 2013 --> Jul 2013 Not yet recruiting --> Recruiting

|||||||||| Enrollment closed: Post-traumatic Stress Disorder (PTSD), Addiction, and Virtual Reality (clinicaltrials.gov) - Jul 23, 2013
P=N/A, N=60, Active, not recruiting, Sponsor: Duke University
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting

|||||||||| Enrollment change: The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment (clinicaltrials.gov) - Jul 18, 2013
P=N/A, N=60, Completed, Sponsor: Yale University
Recruiting --> Active, not recruiting N=90 --> 60

|||||||||| New P1 trial: Characterization of [11C]Flumazenil to Image GABA Transmission in Healthy Adult Subjects and Subjects With Alcohol Dependence (clinicaltrials.gov) - Jul 18, 2013
P1, N=11, Terminated, Sponsor: Rajesh Narendran

|||||||||| Trial completion: The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment (clinicaltrials.gov) - Jul 18, 2013
P=N/A, N=60, Completed, Sponsor: Yale University
N=90 --> 60 Active, not recruiting --> Completed

||||||||||  Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma
New P4 trial, Adherence:  Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence (clinicaltrials.gov) -  Jul 17, 2013
P4, N=700, Recruiting,  Sponsor: Orexo AB

||||||||||  Arcalyst (rilonacept) / Regeneron, Kiniksa
New P2 trial:  A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis (clinicaltrials.gov) -  Jul 17, 2013
P2, N=186, Not yet recruiting,  Sponsor: Timothy Morgan, MD

|||||||||| Enrollment closed: Tobacco Treatment Medical Education in 10 Medical Schools (clinicaltrials.gov) - Jul 17, 2013
P=N/A, N=10, Active, not recruiting, Sponsor: University of Massachusetts, Worcester
Active, not recruiting --> Completed Not yet recruiting --> Active, not recruiting

|||||||||| Enrollment open, Adherence: Project Impact: A Culturally-Tailored Adherence Intervention for Latino Smokers (clinicaltrials.gov) - Jul 16, 2013
P=N/A, N=48, Recruiting, Sponsor: M.D. Anderson Cancer Center
Not yet recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

|||||||||| Enrollment change: Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence (clinicaltrials.gov) - Jul 14, 2013
P3, N=21, Completed, Sponsor: Elizabeth Ralevski
Not yet recruiting --> Recruiting N=30 --> 21

|||||||||| Enrollment open: Retraining Attention to Treat Alcohol Dependence and Social Anxiety (clinicaltrials.gov) - Jul 14, 2013
P=N/A, N=68, Recruiting, Sponsor: University of Cincinnati
N=30 --> 21 Not yet recruiting --> Recruiting

|||||||||| Enrollment change: MEADOW/Bridge: The MEADOW PROJECT (Mending the Effects of Alcohol and Depression on Women) and The Bridge Program (Connecting Recovery Treatment and Behavioral Health) (clinicaltrials.gov) - Jul 11, 2013
P2, N=91, Completed, Sponsor: University of Rochester
Not yet recruiting --> Recruiting N=120 --> 91

|||||||||| Trial completion: MEADOW/Bridge: The MEADOW PROJECT (Mending the Effects of Alcohol and Depression on Women) and The Bridge Program (Connecting Recovery Treatment and Behavioral Health) (clinicaltrials.gov) - Jul 11, 2013
P2, N=91, Completed, Sponsor: University of Rochester
N=120 --> 91 Active, not recruiting --> Completed

||||||||||  isradipine / Generic mfg.
New P1/2 trial:  Improving Buprenorphine Detoxification Outcomes With Isradipine (clinicaltrials.gov) -  Jul 8, 2013
P1/2, N=60, Recruiting,  Sponsor: University of Arkansas

||||||||||  methadone / Generic mfg.
Trial withdrawal:  Naloxone Methadone Combination (NAMEKO) (clinicaltrials.gov) -  Jul 2, 2013
P=N/A, N=0, Withdrawn,  Sponsor: Kuopio University Hospital
Active, not recruiting --> Completed Not yet recruiting --> Withdrawn

||||||||||  phenobarbital / Generic mfg., clonidine / Generic mfg.
Trial termination:  Clonidine for Neonatal Abstinence Syndrome Study (clinicaltrials.gov) -  Jul 1, 2013
P=N/A, N=68, Terminated,  Sponsor: Baystate Medical Center
Not yet recruiting --> Withdrawn Recruiting --> Terminated; Based on the planned interim analysis results at 50% recruitment, after IRB reviewed the results, further enrollment was stopped.