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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

127 participants

Primary outcome timeframe

16 days (prequit baseline and 15 days of abstinence)

Results posted on

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

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

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

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

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

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

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 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.

Outcome measures

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 abstinence

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

Outcome measures

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

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 abstinence

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

Outcome measures

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 abstinence

Heart rate measured during laboratory assessment sessions.

Outcome measures

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 abstinence

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

Outcome measures

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

Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths

Placebo Patch

Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: 618-453-3527

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place