Trial Outcomes & Findings for Nicotine Patch for Marijuana Withdrawal (NCT NCT01400243)
NCT ID: NCT01400243
Last Updated: 2015-04-30
Results Overview
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.
COMPLETED
PHASE4
127 participants
16 days (prequit baseline and 15 days of abstinence)
2015-04-30
Participant Flow
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.
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.
Participant milestones
| Measure |
Placebo Patch
Placebo patch for 15-day quit period
Placebo Patch: Placebo patch
|
Nicotine Patch
7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
63
|
|
Overall Study
COMPLETED
|
56
|
52
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
| Measure |
Placebo Patch
Placebo patch for 15-day quit period
Placebo Patch: Placebo patch
|
Nicotine Patch
7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg
|
|---|---|---|
|
Overall Study
Protocol Violation
|
8
|
11
|
Baseline Characteristics
Nicotine Patch for Marijuana Withdrawal
Baseline characteristics by cohort
| Measure |
Placebo Patch
n=64 Participants
Placebo patch for 15-day quit period
Placebo Patch: Placebo patch
|
Nicotine Patch
n=63 Participants
7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
20.57 years
STANDARD_DEVIATION 2.43 • n=99 Participants
|
21.19 years
STANDARD_DEVIATION 3.86 • n=107 Participants
|
20.87 years
STANDARD_DEVIATION 3.20 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=99 Participants
|
63 participants
n=107 Participants
|
127 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Placebo Patch
n=56 Participants
Placebo patch for 15-day quit period
Placebo Patch: Placebo patch
|
Nicotine Patch
n=52 Participants
7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg
|
|---|---|---|
|
Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
Baseline POMS Total Negative
|
8.52 units on a scale
Standard Error 1.48
|
8.096 units on a scale
Standard Error 1.54
|
|
Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
Post-Quit Day 1 POMS Total Negative
|
5.14 units on a scale
Standard Error 1.66
|
4.615 units on a scale
Standard Error 1.72
|
|
Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
Post-Quit Day 3 POMS Total Negative
|
6.73 units on a scale
Standard Error 1.67
|
7.48 units on a scale
Standard Error 1.73
|
|
Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
Post-Quit Day 5 POMS Total Negative
|
7.86 units on a scale
Standard Error 1.52
|
6.62 units on a scale
Standard Error 1.58
|
|
Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
Post-Quit Day 7 POMS Total Negative
|
10.34 units on a scale
Standard Error 2.45
|
8.60 units on a scale
Standard Error 2.54
|
|
Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
Post-Quit Day 9 POMS Total Negative
|
7.36 units on a scale
Standard Error 1.74
|
6.87 units on a scale
Standard Error 1.8
|
|
Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
Post-Quit Day 11 POMS Total Negative
|
8.30 units on a scale
Standard Error 1.92
|
7.23 units on a scale
Standard Error 1.99
|
|
Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
Post-Quit Day 13 POMS Total Negative
|
6.66 units on a scale
Standard Error 1.64
|
5.31 units on a scale
Standard Error 1.71
|
|
Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
Post-Quit Day 15 POMS Total Negative
|
6.61 units on a scale
Standard Error 1.73
|
5.10 units on a scale
Standard Error 1.80
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Placebo Patch
n=56 Participants
Placebo patch for 15-day quit period
Placebo Patch: Placebo patch
|
Nicotine Patch
n=52 Participants
7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg
|
|---|---|---|
|
Marijuana Withdrawal Questionnaire (MWC) Total Score
Pre-Quit Baseline MWC
|
4.29 units on a scale
Standard Error 0.59
|
3.67 units on a scale
Standard Error 0.61
|
|
Marijuana Withdrawal Questionnaire (MWC) Total Score
Post-Quit Day 1 MWC
|
3.80 units on a scale
Standard Error 0.53
|
4.35 units on a scale
Standard Error 0.55
|
|
Marijuana Withdrawal Questionnaire (MWC) Total Score
Post-Quit Day 3 MWC
|
5.16 units on a scale
Standard Error 0.75
|
7.12 units on a scale
Standard Error 0.78
|
|
Marijuana Withdrawal Questionnaire (MWC) Total Score
Post-Quit Day 5 MWC
|
5.79 units on a scale
Standard Error 0.80
|
7.02 units on a scale
Standard Error 0.83
|
|
Marijuana Withdrawal Questionnaire (MWC) Total Score
Post-Quit Day 7 MWC
|
6.30 units on a scale
Standard Error 0.84
|
6.98 units on a scale
Standard Error 0.88
|
|
Marijuana Withdrawal Questionnaire (MWC) Total Score
Post-Quit Day 9 MWC
|
5.64 units on a scale
Standard Error 0.75
|
6.04 units on a scale
Standard Error 0.78
|
|
Marijuana Withdrawal Questionnaire (MWC) Total Score
Post-Quit Day 11 MWC
|
5.27 units on a scale
Standard Error 0.81
|
6.56 units on a scale
Standard Error 0.84
|
|
Marijuana Withdrawal Questionnaire (MWC) Total Score
Post-Quit Day 13 MWC
|
5.48 units on a scale
Standard Error 0.76
|
5.23 units on a scale
Standard Error 0.79
|
|
Marijuana Withdrawal Questionnaire (MWC) Total Score
Post-Quit Day 15 MWC
|
5.11 units on a scale
Standard Error 0.66
|
5.02 units on a scale
Standard Error 0.68
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Placebo Patch
n=52 Participants
Placebo patch for 15-day quit period
Placebo Patch: Placebo patch
|
Nicotine Patch
n=56 Participants
7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg
|
|---|---|---|
|
POMS Vigor/Positive Affect (PA)
Pre-Quit Baseline Vigor/PA
|
12.45 units on a scale
Standard Error 0.82
|
11.18 units on a scale
Standard Error 0.79
|
|
POMS Vigor/Positive Affect (PA)
Post-Quit Day 1 Vigor/PA
|
12.97 units on a scale
Standard Error 0.87
|
10.72 units on a scale
Standard Error 0.84
|
|
POMS Vigor/Positive Affect (PA)
Post-Quit Day 3 Vigor/PA
|
13.82 units on a scale
Standard Error 0.86
|
12.34 units on a scale
Standard Error 0.83
|
|
POMS Vigor/Positive Affect (PA)
Post-Quit Day 5 Vigor/PA
|
14.19 units on a scale
Standard Error 0.84
|
12.35 units on a scale
Standard Error 0.81
|
|
POMS Vigor/Positive Affect (PA)
Post-Quit Day 7 Vigor/PA
|
14.40 units on a scale
Standard Error 0.90
|
11.94 units on a scale
Standard Error 0.86
|
|
POMS Vigor/Positive Affect (PA)
Post-Quit Day 9 Vigor/PA
|
14.59 units on a scale
Standard Error 0.91
|
12.52 units on a scale
Standard Error 0.88
|
|
POMS Vigor/Positive Affect (PA)
Post-Quit Day 11 Vigor/PA
|
14.51 units on a scale
Standard Error 0.85
|
11.94 units on a scale
Standard Error 0.82
|
|
POMS Vigor/Positive Affect (PA)
Post-Quit Day 13 Vigor/PA
|
14.43 units on a scale
Standard Error 0.85
|
12.54 units on a scale
Standard Error 0.82
|
|
POMS Vigor/Positive Affect (PA)
Post-Quit Day 15 Vigor/PA
|
15.37 units on a scale
Standard Error 0.88
|
12.15 units on a scale
Standard Error 0.85
|
SECONDARY outcome
Timeframe: Day 15 of abstinenceThe 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.
Outcome measures
| Measure |
Placebo Patch
n=56 Participants
Placebo patch for 15-day quit period
Placebo Patch: Placebo patch
|
Nicotine Patch
n=52 Participants
7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg
|
|---|---|---|
|
Patch Guess and Attributions Questionnaire
|
49.23 Percentage chance on nicotine patch
Standard Error 4.23
|
59.85 Percentage chance on nicotine patch
Standard Error 3.59
|
SECONDARY outcome
Timeframe: From baseline to Day 15 of abstinenceSystolic blood pressure was measured in mmHg during each experimental session prior and subsequent to quitting marijuana.
Outcome measures
| Measure |
Placebo Patch
n=52 Participants
Placebo patch for 15-day quit period
Placebo Patch: Placebo patch
|
Nicotine Patch
n=56 Participants
7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg
|
|---|---|---|
|
Systolic Blood Pressure (SBP)
Pre-Quit Baseline SBP
|
115.31 mmHg
Standard Error 1.72
|
113.48 mmHg
Standard Error 1.66
|
|
Systolic Blood Pressure (SBP)
Quit-Day 1 SBP
|
119.42 mmHg
Standard Error 1.82
|
115.21 mmHg
Standard Error 1.75
|
|
Systolic Blood Pressure (SBP)
Quit-Day 3 SBP
|
120.85 mmHg
Standard Error 1.74
|
115.00 mmHg
Standard Error 1.68
|
|
Systolic Blood Pressure (SBP)
Quit-Day 5 SBP
|
120.25 mmHg
Standard Error 1.82
|
117.64 mmHg
Standard Error 1.75
|
|
Systolic Blood Pressure (SBP)
Quit-Day 7 SBP
|
121.02 mmHg
Standard Error 1.91
|
115.77 mmHg
Standard Error 1.84
|
|
Systolic Blood Pressure (SBP)
Quit-Day 9 SBP
|
118.50 mmHg
Standard Error 1.75
|
116.73 mmHg
Standard Error 1.69
|
|
Systolic Blood Pressure (SBP)
Quit-Day 11 SBP
|
120.21 mmHg
Standard Error 1.85
|
115.80 mmHg
Standard Error 1.79
|
|
Systolic Blood Pressure (SBP)
Quit-Day 13 SBP
|
120.58 mmHg
Standard Error 1.68
|
115.63 mmHg
Standard Error 1.62
|
|
Systolic Blood Pressure (SBP)
Quit-Day 15 SBP
|
120.69 mmHg
Standard Error 1.78
|
115.07 mmHg
Standard Error 1.71
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Placebo Patch
n=52 Participants
Placebo patch for 15-day quit period
Placebo Patch: Placebo patch
|
Nicotine Patch
n=56 Participants
7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg
|
|---|---|---|
|
Tobacco and Nicotine Intake
Pre-Treatment Tobacco/Week
|
5.47 Cigarettes per 30 days
Standard Error 3.28
|
7.75 Cigarettes per 30 days
Standard Error 3.13
|
|
Tobacco and Nicotine Intake
Post-Treatment Tobacco/Week
|
0.23 Cigarettes per 30 days
Standard Error 3.87
|
6.66 Cigarettes per 30 days
Standard Error 3.70
|
SECONDARY outcome
Timeframe: across baseline and at 3, 5, 7, 9, 11, 13, and 15 days of abstinenceTetrahydrocannabinol (THC) Intake assessed by assessing urine sample creatinine corrected THC in ng/ml urine.
Outcome measures
| Measure |
Placebo Patch
n=52 Participants
Placebo patch for 15-day quit period
Placebo Patch: Placebo patch
|
Nicotine Patch
n=56 Participants
7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg
|
|---|---|---|
|
Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.
Pre-Quit Baseline THC
|
343.35 ng/ml urine creatinine-corrected THC
Standard Error 78.40
|
400.84 ng/ml urine creatinine-corrected THC
Standard Error 75.55
|
|
Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.
Post-Quit Day 3 THC
|
102.16 ng/ml urine creatinine-corrected THC
Standard Error 20.43
|
128.49 ng/ml urine creatinine-corrected THC
Standard Error 19.68
|
|
Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.
Post-Quit Day 5 THC
|
61.02 ng/ml urine creatinine-corrected THC
Standard Error 9.17
|
73.07 ng/ml urine creatinine-corrected THC
Standard Error 8.83
|
|
Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.
Post-Quit Day 7 THC
|
43.86 ng/ml urine creatinine-corrected THC
Standard Error 6.28
|
54.45 ng/ml urine creatinine-corrected THC
Standard Error 6.05
|
|
Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.
Post-Quit Day 9 THC
|
32.61 ng/ml urine creatinine-corrected THC
Standard Error 4.35
|
38.25 ng/ml urine creatinine-corrected THC
Standard Error 4.19
|
|
Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.
Post-Quit Day 11 THC
|
26.27 ng/ml urine creatinine-corrected THC
Standard Error 3.95
|
33.31 ng/ml urine creatinine-corrected THC
Standard Error 3.81
|
|
Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.
Post-Quit Day 13 THC
|
20.04 ng/ml urine creatinine-corrected THC
Standard Error 2.94
|
27.35 ng/ml urine creatinine-corrected THC
Standard Error 2.82
|
|
Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.
Post-Quit Day 15 THC
|
19.97 ng/ml urine creatinine-corrected THC
Standard Error 2.88
|
23.70 ng/ml urine creatinine-corrected THC
Standard Error 2.78
|
SECONDARY outcome
Timeframe: Baseline through Day 15 of abstinenceHeart rate measured during laboratory assessment sessions.
Outcome measures
| Measure |
Placebo Patch
n=52 Participants
Placebo patch for 15-day quit period
Placebo Patch: Placebo patch
|
Nicotine Patch
n=56 Participants
7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg
|
|---|---|---|
|
Heart Rate
Pre-Quit Baseline Heart Rate
|
65.44 beats per minute
Standard Error 1.47
|
67.86 beats per minute
Standard Error 1.42
|
|
Heart Rate
Post-Quit Day 1 Heart Rate
|
69.54 beats per minute
Standard Error 1.46
|
65.98 beats per minute
Standard Error 1.40
|
|
Heart Rate
Post-Quit Day 3 Heart Rate
|
73.0 beats per minute
Standard Error 1.60
|
68.80 beats per minute
Standard Error 1.54
|
|
Heart Rate
Post-Quit Day 5 Heart Rate
|
73.25 beats per minute
Standard Error 1.71
|
67.91 beats per minute
Standard Error 1.65
|
|
Heart Rate
Post-Quit Day 7 Heart Rate
|
74.04 beats per minute
Standard Error 1.65
|
67.34 beats per minute
Standard Error 1.59
|
|
Heart Rate
Post-Quit Day 9 Heart Rate
|
75.83 beats per minute
Standard Error 1.67
|
69.36 beats per minute
Standard Error 1.61
|
|
Heart Rate
Post-Quit Day 11 Heart Rate
|
73.02 beats per minute
Standard Error 1.84
|
70.89 beats per minute
Standard Error 1.78
|
|
Heart Rate
Post-Quit Day 13 Heart Rate
|
75.42 beats per minute
Standard Error 1.64
|
69.88 beats per minute
Standard Error 1.58
|
|
Heart Rate
Post-Quit Day 15 Heart Rate
|
72.50 beats per minute
Standard Error 1.58
|
70.64 beats per minute
Standard Error 1.52
|
SECONDARY outcome
Timeframe: From baseline to Day 15 of abstinenceDiastolic blood pressure measured during each of the experimental sessions-- baseline through 15-days post-quit.
Outcome measures
| Measure |
Placebo Patch
n=52 Participants
Placebo patch for 15-day quit period
Placebo Patch: Placebo patch
|
Nicotine Patch
n=56 Participants
7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg
|
|---|---|---|
|
Diastolic Blood Pressure (DBP)
Pre-Quit Baseline DBP
|
65.06 mm Hg
Standard Error 1.27
|
68.05 mm Hg
Standard Error 1.23
|
|
Diastolic Blood Pressure (DBP)
Post-Quit Day 1 DBP
|
69.94 mm Hg
Standard Error 1.07
|
68.32 mm Hg
Standard Error 1.03
|
|
Diastolic Blood Pressure (DBP)
Post-Quit Day 3 DBP
|
72.60 mm Hg
Standard Error 1.28
|
67.88 mm Hg
Standard Error 1.24
|
|
Diastolic Blood Pressure (DBP)
Post-Quit Day 5 DBP
|
73.02 mm Hg
Standard Error 1.21
|
69.46 mm Hg
Standard Error 1.17
|
|
Diastolic Blood Pressure (DBP)
Post-Quit Day 7 DBP
|
71.62 mm Hg
Standard Error 1.25
|
68.52 mm Hg
Standard Error 1.21
|
|
Diastolic Blood Pressure (DBP)
Post-Quit Day 9 DBP
|
70.54 mm Hg
Standard Error 1.08
|
69.29 mm Hg
Standard Error 1.04
|
|
Diastolic Blood Pressure (DBP)
Post-Quit Day 11 DBP
|
72.50 mm Hg
Standard Error 1.17
|
71.57 mm Hg
Standard Error 1.13
|
|
Diastolic Blood Pressure (DBP)
Post-Quit Day 13 DBP
|
71.19 mm Hg
Standard Error 1.21
|
70.98 mm Hg
Standard Error 1.17
|
|
Diastolic Blood Pressure (DBP)
Post-Quit Day 15 DBP
|
72.75 mm Hg
Standard Error 1.32
|
69.55 mm Hg
Standard Error 1.27
|
Adverse Events
Nicotine Patch
Placebo Patch
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nicotine Patch
n=63 participants at risk
7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg
|
Placebo Patch
n=64 participants at risk
Placebo patch for 15-day quit period
Placebo Patch: Placebo patch
|
|---|---|---|
|
General disorders
Any nonserious adverse event
|
65.1%
41/63
|
62.5%
40/64
|
|
Skin and subcutaneous tissue disorders
Itchiness at Patch Site
|
22.2%
14/63
|
9.4%
6/64
|
|
Skin and subcutaneous tissue disorders
Redness at patch site
|
7.9%
5/63
|
7.8%
5/64
|
|
Gastrointestinal disorders
Nausea
|
15.9%
10/63
|
6.2%
4/64
|
|
Nervous system disorders
Sleep disturbance
|
0.00%
0/63
|
7.8%
5/64
|
|
General disorders
Headache
|
4.8%
3/63
|
1.6%
1/64
|
|
General disorders
Lucid dreams
|
1.6%
1/63
|
4.7%
3/64
|
|
General disorders
Lightheadedness
|
1.6%
1/63
|
1.6%
1/64
|
|
General disorders
Decreased appetite
|
4.8%
3/63
|
9.4%
6/64
|
|
General disorders
Increased appetite
|
0.00%
0/63
|
4.7%
3/64
|
|
General disorders
Hot or sweating
|
1.6%
1/63
|
0.00%
0/64
|
Additional Information
David G. Gilbert
Southern Illinois University Carbondale
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place