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NMW: Nicotine Patch for Marijuana Withdrawal

Sponsor
Southern Illinois University Carbondale (Other)
Overall Status
Completed
CT.gov ID
NCT01400243
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
127
Enrollment
1
Location
2
Arms
38
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this 3-year trial is to test the efficacy of transdermal nicotine patch versus placebo patch on marijuana withdrawal symptoms in cannabis-dependent individuals, using a randomized, double-blind, and placebo-controlled design. This proposal is in response to RFA-DA-10-016(R01) Medications Development for Cannabis-Related Disorders. Consistent with the goals of this RFA, the overall goal of the proposed project is to assess the impact of transdermal nicotine patch (TNP) on marijuana (MJ) withdrawal (negative affect and craving motivated by negative affect) symptoms in MJ-dependent individuals.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The aim of this proposal is to accurately assess the effects of TNP on MJ withdrawal symptoms across 15 days of biochemically confirmed MJ abstinence using a placebo-controlled, double-blind, randomly assigned treatment design, while closely monitoring any potential adverse effects, including changes in nicotine use and dependence.

To achieve these goals, 116 carefully screened cannabis-dependent individuals (58 female) will be randomly assigned to one of two doses (0 mg or 7mg nicotine) of TNP (transdermal nicotine patch) while they abstain from MJ for 15 days. Subjects will be administered a follow-up phone interview 30 days after the termination of treatment to assess the effects of nicotine-patch treatment on: 1) frequency of nicotine and tobacco smoking intake, 2) Fagerstrom Test of Nicotine Dependence (FTND)-assessed nicotine dependence, 3) new use of nicotine during the time since completion of the study, and 4) marijuana and other drug use patterns. Large financial contingencies will be used to provide a high degree of abstinence and study completion. This will be the first adequately powered study to assess the effects of TNP on MJ negative affect-related withdrawal symptoms and urges to use MJ. Withdrawal patterns and abstinence will be assessed in two groups of MJ-dependent individuals: 1) those who rarely or never smoke tobacco, and 2) those who smoke four or fewer tobacco cigarettes per day (very-light tobacco smokers). A stratified randomization method will be used to control for gender and tobacco-smoker status. It is hypothesized that MJ withdrawal symptoms will be less severe in the group assigned to the 7 mg patch than in the group assigned to the placebo. It is also hypothesized that individuals high in anxiety/neuroticism and those high in aggression/hostility will exhibit greater benefits from TNP than those low in these traits. Given that no gender differences were observed in our preliminary study, gender differences are not predicted. The over-the-counter availability, minimal abuse risks, and minimal adverse side-effects associated with TNP would make it an ideal and highly implementable treatment for MJ dependence if it can be demonstrated to be efficacious in reducing MJ withdrawal symptoms.

Study Design

Study Type:
Interventional
Actual Enrollment :
127 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Nicotine for Marijuana Withdrawal
Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo Patch

Placebo patch for 15-day quit period

Drug: Placebo Patch
Placebo patch
Other Names:
  • Placebo patch from Rejuvenations Lab

    		•
    Active Comparator: Nicotine Patch

    7 mg Habitrol nicotine patch-15 day quit period

    Drug: Nicotine
    Nicotine patch 7mg
    Other Names:
  • Habitrol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) [16 days (prequit baseline and 15 days of abstinence)]

      POMS Total negative affect was assessed during the final pre-quit baseline session and the 8 post-quit sessions (1, 3, 5, 7, 9, 11, 13, and 15 days post-quit). The Total negative affect score has a minimum potential value of "0" = best possibly level and a maximum value of "154" = worst possible level.

    2. Marijuana Withdrawal Questionnaire (MWC) Total Score [16 days (prequit baseline and at 1, 3, 5, 7, 9, 11, 13, and 15 days of abstinence)]

      The Marijuana Withdrawal Questionnaire Total Score includes items assessing anxiety, depression, irritability, appetite, aggression/anger, sleep disturbance, somatic disturbances, and craving to use marijuana. The potential range of this total score is from "0" = no withdrawal symptoms to "47" = maximally high levels of withdrawal.

    3. POMS Vigor/Positive Affect (PA) [16 days (baseline through day 15 of treatment)]

      Profile of Mood State questionnaire Vigor/Positive Affect scale. The potential range of the Vigor/Positive Affect scale is from "0" (no vigor) to "32" (maximally high vigor score).

    Secondary Outcome Measures

    1. Patch Guess and Attributions Questionnaire [Day 15 of abstinence]

      The Patch Guess and Attributions Questionnaire assesses which type of patch (active versus placebo) the subject believes that he or she was given during the study. This assessment was made at end of treatment (Day 15 of abstinence), the last day on a patch. Scores range from 0 percent to 100 percent chance of being on the nicotine patch for those actually on the placebo patch and from 0 percent to 100 percent chance of being on the nicotine patch for those subjects actually on the nicotine patch. Each subject was asked to indicate the percentage chance that he or she was on the nicotine (as opposed to the placebo) patch. The mean values reported below are the group mean percentage averages.

    2. Systolic Blood Pressure (SBP) [From baseline to Day 15 of abstinence]

      Systolic blood pressure was measured in mmHg during each experimental session prior and subsequent to quitting marijuana.

    3. Tobacco and Nicotine Intake [Basesline 30 days prior to study and during the 30 days following the 15-day abstinence phase.]

      Nicotine intake was assessed by self-reported tobacco cigarettes per month (30 days) at baseline (prior to treatment) and also across the 30 days starting immediately after the end of treatment.

    4. Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. [across baseline and at 3, 5, 7, 9, 11, 13, and 15 days of abstinence]

      Tetrahydrocannabinol (THC) Intake assessed by assessing urine sample creatinine corrected THC in ng/ml urine.

    5. Heart Rate [Baseline through Day 15 of abstinence]

      Heart rate measured during laboratory assessment sessions.

    6. Diastolic Blood Pressure (DBP) [From baseline to Day 15 of abstinence]

      Diastolic blood pressure measured during each of the experimental sessions-- baseline through 15-days post-quit.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: Female and male cannabis-dependent MJ smokers aged 18 years or older will be recruited. Inclusion criteria include cannabis dependence as assessed by a Diagnostic and Statistical Manual (DSM-IV)-based structured interview and MJ use on 10-28 occasions per week and be willing to abstain for 15 days. Only individuals who are in good mental and physical health, with a BMI of 17-30 kg/m2, as verified by health questionnaires and the Structured Clinical Interview for DSM-IV (SCID), will participate in this study. Potential subjects will be asked to indicate, on a scale of 1-10, how strong they currently want to quit smoking MJ (from "1" = "not at all" to "10" = "very strong") and will also be assessed with the four-item MJ Stages of Change. Additionally, subjects will fulfill one of two criteria: 1) not smoke or use other tobacco products or 2) smoke tobacco cigarettes or use other nicotine delivery systems (e.g., hookah, cigars, chewing tobacco) fewer than 5 times per day (on average) for the past year. Current use of MJ and tobacco will be verified by detectable urine Tetrahydrocannabinol (THC) and nicotine metabolites. All subjects will be required to provide four pre-quit baseline urine samples. The mean creatinine-normalized THC concentration across these samples must be of 175 ng/ml or greater based. -

    Exclusion Criteria:

    Criteria include meeting DSM-IV criteria for current abuse or dependence on a substance other than MJ, nicotine, or caffeine, using psychoactive substances (other than MJ, alcohol, nicotine, & caffeine) 6+ times/month, testing positive for stimulants, antidepressants, anxiolytics, and/or opiates (10-panel urine drug test), testing above a salivary cotinine concentration of 150 ng/ml during the initial screening, using creatinine or creatinine-containing supplements, testing positive for adulteration of urine samples, consuming more than 6 alcoholic drinks per day continuously for a month, mental disorders including bipolar disorder, schizophrenia, psychotic symptoms, currently, recently, or ever chronically at significant suicidal risk or experiencing violent thoughts or current major depression. Others that will be excluded include women who are pregnant, lactating, not taking precautions to avoid pregnancy, individuals with significant physical disorders or unstable physical disorders that may represent a severe untreated condition, such as hypertension, as well as those with less than a high school education or equivalent, primary language other than English, and those with significant cognitive impairment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southern Illinois University Carbondale Illinois United States 62901

    Sponsors and Collaborators

    • Southern Illinois University Carbondale
    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Principal Investigator: David G Gilbert, PhD, Southern Illinois University Carbondale

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southern Illinois University Carbondale
    ClinicalTrials.gov Identifier:
    NCT01400243
    Other Study ID Numbers:
    • NIH/NIDA 1R01DA031006 - 01
    • R01DA031006
    First Posted:
    Jul 22, 2011
    Last Update Posted:
    Apr 30, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Southern Illinois University Carbondale
    Marijuana
    Drug withdrawal symptoms
    Nicotine
    Additional relevant MeSH terms:
    Marijuana Abuse
    Nicotine

    Study Results

    Participant Flow

    Recruitment Details Female and male cannabis-dependent individuals 18 years or older were recruited by flyers and advertisements in newspapers to participate in the study in the locally well-know Southern Illinois University Integrative Neuroscience Laboratory and Smoking Lab.
    Pre-assignment Detail During four sessions across three weeks prior to quitting the use of marijuana, subjects completed questionnaires that assessed mood, drug use, urge to use marijuana (MJ), questionnaires, and motivation to quit MJ, and provided urine, saliva, and expired breath samples for the level of marijuana and other drug use level.
    Arm/Group Title Placebo Patch Nicotine Patch
    Arm/Group Description Placebo patch for 15-day quit period Placebo Patch: Placebo patch 7 mg Habitrol nicotine patch-15 day quit period Nicotine: Nicotine patch 7mg
    Period Title: Overall Study
    STARTED 64 63
    COMPLETED 56 52
    NOT COMPLETED 8 11

    Baseline Characteristics

    Arm/Group Title Placebo Patch Nicotine Patch Total
    Arm/Group Description Placebo patch for 15-day quit period Placebo Patch: Placebo patch 7 mg Habitrol nicotine patch-15 day quit period Nicotine: Nicotine patch 7mg Total of all reporting groups
    Overall Participants 64 63 127
    Age (years) [Mean (Standard Deviation) ]
    Age
    20.57
    (2.43)
    21.19
    (3.86)
    20.87
    (3.20)
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    64
    100%
    63
    100%
    127
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    22
    34.4%
    16
    25.4%
    38
    29.9%
    Male
    42
    65.6%
    47
    74.6%
    89
    70.1%
    Region of Enrollment (participants) [Number]
    United States
    64
    100%
    63
    100%
    127
    100%

    Outcome Measures

    1. Primary Outcome
    Title Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
    Description POMS Total negative affect was assessed during the final pre-quit baseline session and the 8 post-quit sessions (1, 3, 5, 7, 9, 11, 13, and 15 days post-quit). The Total negative affect score has a minimum potential value of "0" = best possibly level and a maximum value of "154" = worst possible level.
    Time Frame 16 days (prequit baseline and 15 days of abstinence)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Placebo Patch Nicotine Patch
    Arm/Group Description Placebo patch for 15-day quit period Placebo Patch: Placebo patch 7 mg Habitrol nicotine patch-15 day quit period Nicotine: Nicotine patch 7mg
    Measure Participants 56 52
    Baseline POMS Total Negative
    8.52
    (1.48)
    8.096
    (1.54)
    Post-Quit Day 1 POMS Total Negative
    5.14
    (1.66)
    4.615
    (1.72)
    Post-Quit Day 3 POMS Total Negative
    6.73
    (1.67)
    7.48
    (1.73)
    Post-Quit Day 5 POMS Total Negative
    7.86
    (1.52)
    6.62
    (1.58)
    Post-Quit Day 7 POMS Total Negative
    10.34
    (2.45)
    8.60
    (2.54)
    Post-Quit Day 9 POMS Total Negative
    7.36
    (1.74)
    6.87
    (1.8)
    Post-Quit Day 11 POMS Total Negative
    8.30
    (1.92)
    7.23
    (1.99)
    Post-Quit Day 13 POMS Total Negative
    6.66
    (1.64)
    5.31
    (1.71)
    Post-Quit Day 15 POMS Total Negative
    6.61
    (1.73)
    5.10
    (1.80)
    2. Secondary Outcome
    Title Patch Guess and Attributions Questionnaire
    Description The Patch Guess and Attributions Questionnaire assesses which type of patch (active versus placebo) the subject believes that he or she was given during the study. This assessment was made at end of treatment (Day 15 of abstinence), the last day on a patch. Scores range from 0 percent to 100 percent chance of being on the nicotine patch for those actually on the placebo patch and from 0 percent to 100 percent chance of being on the nicotine patch for those subjects actually on the nicotine patch. Each subject was asked to indicate the percentage chance that he or she was on the nicotine (as opposed to the placebo) patch. The mean values reported below are the group mean percentage averages.
    Time Frame Day 15 of abstinence

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Placebo Patch Nicotine Patch
    Arm/Group Description Placebo patch for 15-day quit period Placebo Patch: Placebo patch 7 mg Habitrol nicotine patch-15 day quit period Nicotine: Nicotine patch 7mg
    Measure Participants 56 52
    Mean (Standard Error) [Percentage chance on nicotine patch]
    49.23
    (4.23)
    59.85
    (3.59)
    3. Secondary Outcome
    Title Systolic Blood Pressure (SBP)
    Description Systolic blood pressure was measured in mmHg during each experimental session prior and subsequent to quitting marijuana.
    Time Frame From baseline to Day 15 of abstinence

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Nicotine Patch Placebo Patch
    Arm/Group Description 7 mg Habitrol nicotine patch-15 day quit period Nicotine: Nicotine patch 7mg Placebo patch for 15-day quit period Placebo Patch: Placebo patch
    Measure Participants 52 56
    Pre-Quit Baseline SBP
    115.31
    (1.72)
    113.48
    (1.66)
    Quit-Day 1 SBP
    119.42
    (1.82)
    115.21
    (1.75)
    Quit-Day 3 SBP
    120.85
    (1.74)
    115.00
    (1.68)
    Quit-Day 5 SBP
    120.25
    (1.82)
    117.64
    (1.75)
    Quit-Day 7 SBP
    121.02
    (1.91)
    115.77
    (1.84)
    Quit-Day 9 SBP
    118.50
    (1.75)
    116.73
    (1.69)
    Quit-Day 11 SBP
    120.21
    (1.85)
    115.80
    (1.79)
    Quit-Day 13 SBP
    120.58
    (1.68)
    115.63
    (1.62)
    Quit-Day 15 SBP
    120.69
    (1.78)
    115.07
    (1.71)
    4. Secondary Outcome
    Title Tobacco and Nicotine Intake
    Description Nicotine intake was assessed by self-reported tobacco cigarettes per month (30 days) at baseline (prior to treatment) and also across the 30 days starting immediately after the end of treatment.
    Time Frame Basesline 30 days prior to study and during the 30 days following the 15-day abstinence phase.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Nicotine Patch Placebo Patch
    Arm/Group Description 7 mg Habitrol nicotine patch-15 day quit period Nicotine: Nicotine patch 7mg Placebo patch for 15-day quit period Placebo Patch: Placebo patch
    Measure Participants 52 56
    Pre-Treatment Tobacco/Week
    5.47
    (3.28)
    7.75
    (3.13)
    Post-Treatment Tobacco/Week
    0.23
    (3.87)
    6.66
    (3.70)
    5. Secondary Outcome
    Title Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.
    Description Tetrahydrocannabinol (THC) Intake assessed by assessing urine sample creatinine corrected THC in ng/ml urine.
    Time Frame across baseline and at 3, 5, 7, 9, 11, 13, and 15 days of abstinence

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Nicotine Patch Placebo Patch
    Arm/Group Description 7 mg Habitrol nicotine patch-15 day quit period Nicotine: Nicotine patch 7mg Placebo patch for 15-day quit period Placebo Patch: Placebo patch
    Measure Participants 52 56
    Pre-Quit Baseline THC
    343.35
    (78.40)
    400.84
    (75.55)
    Post-Quit Day 3 THC
    102.16
    (20.43)
    128.49
    (19.68)
    Post-Quit Day 5 THC
    61.02
    (9.17)
    73.07
    (8.83)
    Post-Quit Day 7 THC
    43.86
    (6.28)
    54.45
    (6.05)
    Post-Quit Day 9 THC
    32.61
    (4.35)
    38.25
    (4.19)
    Post-Quit Day 11 THC
    26.27
    (3.95)
    33.31
    (3.81)
    Post-Quit Day 13 THC
    20.04
    (2.94)
    27.35
    (2.82)
    Post-Quit Day 15 THC
    19.97
    (2.88)
    23.70
    (2.78)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo Patch, Nicotine Patch
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value .05
    Comments
    Method ANCOVA
    Comments
    6. Secondary Outcome
    Title Heart Rate
    Description Heart rate measured during laboratory assessment sessions.
    Time Frame Baseline through Day 15 of abstinence

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Nicotine Patch Placebo Patch
    Arm/Group Description 7 mg Habitrol nicotine patch-15 day quit period Nicotine: Nicotine patch 7mg Placebo patch for 15-day quit period Placebo Patch: Placebo patch
    Measure Participants 52 56
    Pre-Quit Baseline Heart Rate
    65.44
    (1.47)
    67.86
    (1.42)
    Post-Quit Day 1 Heart Rate
    69.54
    (1.46)
    65.98
    (1.40)
    Post-Quit Day 3 Heart Rate
    73.0
    (1.60)
    68.80
    (1.54)
    Post-Quit Day 5 Heart Rate
    73.25
    (1.71)
    67.91
    (1.65)
    Post-Quit Day 7 Heart Rate
    74.04
    (1.65)
    67.34
    (1.59)
    Post-Quit Day 9 Heart Rate
    75.83
    (1.67)
    69.36
    (1.61)
    Post-Quit Day 11 Heart Rate
    73.02
    (1.84)
    70.89
    (1.78)
    Post-Quit Day 13 Heart Rate
    75.42
    (1.64)
    69.88
    (1.58)
    Post-Quit Day 15 Heart Rate
    72.50
    (1.58)
    70.64
    (1.52)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo Patch, Nicotine Patch
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method ANOVA
    Comments
    7. Secondary Outcome
    Title Diastolic Blood Pressure (DBP)
    Description Diastolic blood pressure measured during each of the experimental sessions-- baseline through 15-days post-quit.
    Time Frame From baseline to Day 15 of abstinence

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Nicotine Patch Placebo Patch
    Arm/Group Description 7 mg Habitrol nicotine patch-15 day quit period Nicotine: Nicotine patch 7mg Placebo patch for 15-day quit period Placebo Patch: Placebo patch
    Measure Participants 52 56
    Pre-Quit Baseline DBP
    65.06
    (1.27)
    68.05
    (1.23)
    Post-Quit Day 1 DBP
    69.94
    (1.07)
    68.32
    (1.03)
    Post-Quit Day 3 DBP
    72.60
    (1.28)
    67.88
    (1.24)
    Post-Quit Day 5 DBP
    73.02
    (1.21)
    69.46
    (1.17)
    Post-Quit Day 7 DBP
    71.62
    (1.25)
    68.52
    (1.21)
    Post-Quit Day 9 DBP
    70.54
    (1.08)
    69.29
    (1.04)
    Post-Quit Day 11 DBP
    72.50
    (1.17)
    71.57
    (1.13)
    Post-Quit Day 13 DBP
    71.19
    (1.21)
    70.98
    (1.17)
    Post-Quit Day 15 DBP
    72.75
    (1.32)
    69.55
    (1.27)
    8. Primary Outcome
    Title Marijuana Withdrawal Questionnaire (MWC) Total Score
    Description The Marijuana Withdrawal Questionnaire Total Score includes items assessing anxiety, depression, irritability, appetite, aggression/anger, sleep disturbance, somatic disturbances, and craving to use marijuana. The potential range of this total score is from "0" = no withdrawal symptoms to "47" = maximally high levels of withdrawal.
    Time Frame 16 days (prequit baseline and at 1, 3, 5, 7, 9, 11, 13, and 15 days of abstinence)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Placebo Patch Nicotine Patch
    Arm/Group Description Placebo patch for 15-day quit period Placebo Patch: Placebo patch 7 mg Habitrol nicotine patch-15 day quit period Nicotine: Nicotine patch 7mg
    Measure Participants 56 52
    Pre-Quit Baseline MWC
    4.29
    (0.59)
    3.67
    (0.61)
    Post-Quit Day 1 MWC
    3.80
    (0.53)
    4.35
    (0.55)
    Post-Quit Day 3 MWC
    5.16
    (0.75)
    7.12
    (0.78)
    Post-Quit Day 5 MWC
    5.79
    (0.80)
    7.02
    (0.83)
    Post-Quit Day 7 MWC
    6.30
    (0.84)
    6.98
    (0.88)
    Post-Quit Day 9 MWC
    5.64
    (0.75)
    6.04
    (0.78)
    Post-Quit Day 11 MWC
    5.27
    (0.81)
    6.56
    (0.84)
    Post-Quit Day 13 MWC
    5.48
    (0.76)
    5.23
    (0.79)
    Post-Quit Day 15 MWC
    5.11
    (0.66)
    5.02
    (0.68)
    9. Primary Outcome
    Title POMS Vigor/Positive Affect (PA)
    Description Profile of Mood State questionnaire Vigor/Positive Affect scale. The potential range of the Vigor/Positive Affect scale is from "0" (no vigor) to "32" (maximally high vigor score).
    Time Frame 16 days (baseline through day 15 of treatment)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Nicotine Patch Placebo Patch
    Arm/Group Description 7 mg Habitrol nicotine patch-15 day quit period Nicotine: Nicotine patch 7mg Placebo patch for 15-day quit period Placebo Patch: Placebo patch
    Measure Participants 52 56
    Pre-Quit Baseline Vigor/PA
    12.45
    (0.82)
    11.18
    (0.79)
    Post-Quit Day 1 Vigor/PA
    12.97
    (0.87)
    10.72
    (0.84)
    Post-Quit Day 3 Vigor/PA
    13.82
    (0.86)
    12.34
    (0.83)
    Post-Quit Day 5 Vigor/PA
    14.19
    (0.84)
    12.35
    (0.81)
    Post-Quit Day 7 Vigor/PA
    14.40
    (0.90)
    11.94
    (0.86)
    Post-Quit Day 9 Vigor/PA
    14.59
    (0.91)
    12.52
    (0.88)
    Post-Quit Day 11 Vigor/PA
    14.51
    (0.85)
    11.94
    (0.82)
    Post-Quit Day 13 Vigor/PA
    14.43
    (0.85)
    12.54
    (0.82)
    Post-Quit Day 15 Vigor/PA
    15.37
    (0.88)
    12.15
    (0.85)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Nicotine Patch Placebo Patch
    Arm/Group Description 7 mg Habitrol nicotine patch-15 day quit period Nicotine: Nicotine patch 7mg Placebo patch for 15-day quit period Placebo Patch: Placebo patch
    All Cause Mortality
    Nicotine Patch Placebo Patch
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Nicotine Patch Placebo Patch
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/63 (0%) 0/64 (0%)
    Other (Not Including Serious) Adverse Events
    Nicotine Patch Placebo Patch
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 41/63 (65.1%) 40/64 (62.5%)
    Gastrointestinal disorders
    Nausea 10/63 (15.9%) 4/64 (6.3%)
    General disorders
    Any nonserious adverse event 41/63 (65.1%) 40/64 (62.5%)
    Headache 3/63 (4.8%) 1/64 (1.6%)
    Lucid dreams 1/63 (1.6%) 3/64 (4.7%)
    Lightheadedness 1/63 (1.6%) 1/64 (1.6%)
    Decreased appetite 3/63 (4.8%) 6/64 (9.4%)
    Increased appetite 0/63 (0%) 3/64 (4.7%)
    Hot or sweating 1/63 (1.6%) 0/64 (0%)
    Nervous system disorders
    Sleep disturbance 0/63 (0%) 5/64 (7.8%)
    Skin and subcutaneous tissue disorders
    Itchiness at Patch Site 14/63 (22.2%) 6/64 (9.4%)
    Redness at patch site 5/63 (7.9%) 5/64 (7.8%)

    Limitations/Caveats

    The modest sample size limited the ability to precisely characterize how the effects of patch type may be modified by tobacco smoker status, gender, personality traits, and individual differences in marijuana use history.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title David G. Gilbert
    Organization Southern Illinois University Carbondale
    Phone 618-453-3527
    Email dgilbert@siu.edu
    Responsible Party:
    Southern Illinois University Carbondale
    ClinicalTrials.gov Identifier:
    NCT01400243
    Other Study ID Numbers:
    • NIH/NIDA 1R01DA031006 - 01
    • R01DA031006
    First Posted:
    Jul 22, 2011
    Last Update Posted:
    Apr 30, 2015
    Last Verified:
    Apr 1, 2015