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Nicotine Patch for Marijuana Withdrawal (NMW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01400243
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : April 30, 2015
Last Update Posted : April 30, 2015
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Southern Illinois University Carbondale

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Marijuana Dependence
Interventions Drug: Nicotine
Drug: Placebo Patch
Enrollment 127
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 Details 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
Hide 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
Reason Not Completed
Protocol Violation             8             11
Arm/Group Title Placebo Patch Nicotine Patch Total
Hide 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 Number of Baseline Participants 64 63 127
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 64 participants 63 participants 127 participants
20.57  (2.43) 21.19  (3.86) 20.87  (3.20)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 63 participants 127 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
64
 100.0%
63
 100.0%
127
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 63 participants 127 participants
Female
22
  34.4%
16
  25.4%
38
  29.9%
Male
42
  65.6%
47
  74.6%
89
  70.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 64 participants 63 participants 127 participants
64 63 127
1.Primary Outcome
Title Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Patch Nicotine Patch
Hide 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

Overall Number of Participants Analyzed 56 52
Mean (Standard Error)
Unit of Measure: units on a scale
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.Primary Outcome
Title Marijuana Withdrawal Questionnaire (MWC) Total Score
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Patch Nicotine Patch
Hide 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

Overall Number of Participants Analyzed 56 52
Mean (Standard Error)
Unit of Measure: units on a scale
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)
3.Primary Outcome
Title POMS Vigor/Positive Affect (PA)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotine Patch Placebo Patch
Hide 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

Overall Number of Participants Analyzed 52 56
Mean (Standard Error)
Unit of Measure: units on a scale
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)
4.Secondary Outcome
Title Patch Guess and Attributions Questionnaire
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Patch Nicotine Patch
Hide 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

Overall Number of Participants Analyzed 56 52
Mean (Standard Error)
Unit of Measure: Percentage chance on nicotine patch
49.23  (4.23) 59.85  (3.59)
5.Secondary Outcome
Title Systolic Blood Pressure (SBP)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotine Patch Placebo Patch
Hide 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

Overall Number of Participants Analyzed 52 56
Mean (Standard Error)
Unit of Measure: mmHg
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)
6.Secondary Outcome
Title Tobacco and Nicotine Intake
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotine Patch Placebo Patch
Hide 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

Overall Number of Participants Analyzed 52 56
Mean (Standard Error)
Unit of Measure: Cigarettes per 30 days
Pre-Treatment Tobacco/Week 5.47  (3.28) 7.75  (3.13)
Post-Treatment Tobacco/Week 0.23  (3.87) 6.66  (3.70)
7.Secondary Outcome
Title Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotine Patch Placebo Patch
Hide 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

Overall Number of Participants Analyzed 52 56
Mean (Standard Error)
Unit of Measure: ng/ml urine creatinine-corrected THC
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicotine Patch, Placebo Patch
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Heart Rate
Hide Description Heart rate measured during laboratory assessment sessions.
Time Frame Baseline through Day 15 of abstinence
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotine Patch Placebo Patch
Hide 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

Overall Number of Participants Analyzed 52 56
Mean (Standard Error)
Unit of Measure: beats per minute
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicotine Patch, Placebo Patch
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Diastolic Blood Pressure (DBP)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotine Patch Placebo Patch
Hide 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

Overall Number of Participants Analyzed 52 56
Mean (Standard Error)
Unit of Measure: mm Hg
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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nicotine Patch Placebo Patch
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nicotine Patch Placebo Patch
Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/64 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nicotine Patch Placebo Patch
Affected / at Risk (%) Affected / at Risk (%)
Total   41/63 (65.08%)   40/64 (62.50%) 
Gastrointestinal disorders     
Nausea   10/63 (15.87%)  4/64 (6.25%) 
General disorders     
Any nonserious adverse event   41/63 (65.08%)  40/64 (62.50%) 
Headache   3/63 (4.76%)  1/64 (1.56%) 
Lucid dreams   1/63 (1.59%)  3/64 (4.69%) 
Lightheadedness   1/63 (1.59%)  1/64 (1.56%) 
Decreased appetite   3/63 (4.76%)  6/64 (9.38%) 
Increased appetite   0/63 (0.00%)  3/64 (4.69%) 
Hot or sweating   1/63 (1.59%)  0/64 (0.00%) 
Nervous system disorders     
Sleep disturbance   0/63 (0.00%)  5/64 (7.81%) 
Skin and subcutaneous tissue disorders     
Itchiness at Patch Site   14/63 (22.22%)  6/64 (9.38%) 
Redness at patch site   5/63 (7.94%)  5/64 (7.81%) 
Indicates events were collected by systematic assessment
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.
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
Responsible Party: Southern Illinois University Carbondale
ClinicalTrials.gov Identifier: NCT01400243     History of Changes
Other Study ID Numbers: NIH/NIDA 1R01DA031006 - 01
R01DA031006 ( U.S. NIH Grant/Contract )
First Submitted: March 21, 2011
First Posted: July 22, 2011
Results First Submitted: February 20, 2015
Results First Posted: April 30, 2015
Last Update Posted: April 30, 2015