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Nicotine Replacement Therapy

Phase 2

Cannabis Dependence | Small molecule | Other |Harvard Bioscience, Inc.|Last Updated: Aug 14, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01292642Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine DependencePHASE2 COMPLETED 12Aug 1, 2009Jun 1, 2011Aug 14, 20131 United States
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Study Endpoints
Primary Endpoints
Cigarette Use
Baseline and 10 weeks

cigarettes per day

Cannabis Use
Baseline and 10 weeks

cannabis inhalations per day

Secondary Endpoints
Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks
10 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TreatmentEXPERIMENTALCognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study.
Interventions
NameTypeDescription
Cognitive Behavioral TherapyBEHAVIORALindividual CBT once weekly, 50 minutes, for 10 weeks
Nicotine Replacement TherapyDRUG1. 21 mg patch for 6 weeks, 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks 2. 14 m g patch for 8 weeks, then 7 mg patch for 2 weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age range 18-65 years * current DSM-IV cannabis dependence * current DSM-IV nicotine dependence * express a desire to quit cannabis and nicotine use within the next 30 days * daily use of ≥ 10 tobacco cigarettes * for women of childbearing age, a negative pregnancy test at scr...

Countries:United States
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