Trial Outcomes & Findings for Behavioral Memory Modulation in Nicotine Addiction (NCT NCT03744559)
NCT ID: NCT03744559
Last Updated: 2025-04-30
Results Overview
At each visit (baseline, intervention sessions, and follow-up test sessions), participants will complete a Craving Questionnaire survey at multiple timepoints during each visit (baseline, and after each cue exposure). The craving questionnaire is the average of four statements about craving for cigarettes (e.g., "I have an urge for a cigarette"), and the participants rate how they agree with the statements at that moment on a scale of 1 to 5 (1 = strongly disagree and 5 = strongly agree). This measure will examine the behavioral response to the novel cue over the course of the study, and differences in response between the R-E arms and NR-E arms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
191 participants
Primary outcome timeframe
up to 24 weeks, Baseline, 24 hours, Weeks 2, 4, 6, 8, 12, and 24
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
R-E (Retrieval Extinction)
83 anticipated participants will undergo 3 sessions on consecutive days of the Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' smoking-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of smoking-related cues (e.g., pictures). Participants will also receive a lab-based smoking-related cue-reactivity experience during the baseline assessment and 24-hour follow-up test.
|
NR-E (No R-E)
83 anticipated participants will undergo 3 sessions on consecutive days of the control Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' non-smoking or neutral-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of non-smoking or neutral cues (e.g., pictures). Participants will also receive a lab-based non-smoking or neutral cue-reactivity experience during the baseline assessment and 24-hour follow-up test.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
82
|
|
Overall Study
COMPLETED
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
33
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Memory Modulation in Nicotine Addiction
Baseline characteristics by cohort
| Measure |
R-E (Retrieval Extinction)
n=81 Participants
83 anticipated participants will undergo 3 sessions on consecutive days of the Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' smoking-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of smoking-related cues (e.g., pictures). Participants will also receive a lab-based smoking-related cue-reactivity experience during the baseline assessment and 24-hour follow-up test.
|
NR-E (No R-E)
n=82 Participants
83 anticipated participants will undergo 3 sessions on consecutive days of the control Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' non-smoking or neutral-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of non-smoking or neutral cues (e.g., pictures). Participants will also receive a lab-based non-smoking or neutral cue-reactivity experience during the baseline assessment and 24-hour follow-up test.
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
79 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
48.5 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
48.2 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=5 Participants
|
82 participants
n=7 Participants
|
163 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 weeks, Baseline, 24 hours, Weeks 2, 4, 6, 8, 12, and 24Population: Participant included are those randomized to study treatment and return for at least 1 study visit. Mean response to the 4 CQ items and standard deviations to the novel cues are listed.
At each visit (baseline, intervention sessions, and follow-up test sessions), participants will complete a Craving Questionnaire survey at multiple timepoints during each visit (baseline, and after each cue exposure). The craving questionnaire is the average of four statements about craving for cigarettes (e.g., "I have an urge for a cigarette"), and the participants rate how they agree with the statements at that moment on a scale of 1 to 5 (1 = strongly disagree and 5 = strongly agree). This measure will examine the behavioral response to the novel cue over the course of the study, and differences in response between the R-E arms and NR-E arms.
Outcome measures
| Measure |
R-E (Retrieval Extinction)
n=81 Participants
83 anticipated participants will undergo 3 sessions on consecutive days of the Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' smoking-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of smoking-related cues (e.g., pictures). Participants will also receive a lab-based smoking-related cue-reactivity experience during the baseline assessment and 24-hour follow-up test.
|
NR-E (No R-E)
n=79 Participants
83 anticipated participants will undergo 3 sessions on consecutive days of the control Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' non-smoking or neutral-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of non-smoking or neutral cues (e.g., pictures). Participants will also receive a lab-based non-smoking or neutral cue-reactivity experience during the baseline assessment and 24-hour follow-up test.
|
|---|---|---|
|
Mean Craving Questionnaire Score, Response to the Novel Cue
Study Baseline
|
3.43 score on a scale, average of 4 responses
Standard Deviation 0.99
|
3.73 score on a scale, average of 4 responses
Standard Deviation 0.96
|
|
Mean Craving Questionnaire Score, Response to the Novel Cue
24 Hours
|
2.55 score on a scale, average of 4 responses
Standard Deviation 1.16
|
2.88 score on a scale, average of 4 responses
Standard Deviation 1.07
|
|
Mean Craving Questionnaire Score, Response to the Novel Cue
2 Weeks
|
2.40 score on a scale, average of 4 responses
Standard Deviation 0.95
|
2.59 score on a scale, average of 4 responses
Standard Deviation 1.14
|
|
Mean Craving Questionnaire Score, Response to the Novel Cue
6 Weeks
|
2.33 score on a scale, average of 4 responses
Standard Deviation 1.04
|
2.42 score on a scale, average of 4 responses
Standard Deviation 1.05
|
|
Mean Craving Questionnaire Score, Response to the Novel Cue
8 Weeks
|
2.39 score on a scale, average of 4 responses
Standard Deviation 0.95
|
2.25 score on a scale, average of 4 responses
Standard Deviation 1.06
|
|
Mean Craving Questionnaire Score, Response to the Novel Cue
24 Weeks
|
1.96 score on a scale, average of 4 responses
Standard Deviation 1.03
|
1.97 score on a scale, average of 4 responses
Standard Deviation 0.99
|
|
Mean Craving Questionnaire Score, Response to the Novel Cue
4 Weeks
|
2.49 score on a scale, average of 4 responses
Standard Deviation 0.99
|
2.60 score on a scale, average of 4 responses
Standard Deviation 1.09
|
|
Mean Craving Questionnaire Score, Response to the Novel Cue
12 Weeks
|
2.21 score on a scale, average of 4 responses
Standard Deviation 1.08
|
2.31 score on a scale, average of 4 responses
Standard Deviation 1.12
|
PRIMARY outcome
Timeframe: up to 26 weeks, Baseline, Weeks 2, 4, 6, 8, 12, 16, 21 and 26Population: study population includes all participants that returned for a follow up visit at 2-weeks post intervention or later.
Cigarettes Smoked per Day were recorded daily and summarized at follow-up visits
Outcome measures
| Measure |
R-E (Retrieval Extinction)
n=75 Participants
83 anticipated participants will undergo 3 sessions on consecutive days of the Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' smoking-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of smoking-related cues (e.g., pictures). Participants will also receive a lab-based smoking-related cue-reactivity experience during the baseline assessment and 24-hour follow-up test.
|
NR-E (No R-E)
n=73 Participants
83 anticipated participants will undergo 3 sessions on consecutive days of the control Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' non-smoking or neutral-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of non-smoking or neutral cues (e.g., pictures). Participants will also receive a lab-based non-smoking or neutral cue-reactivity experience during the baseline assessment and 24-hour follow-up test.
|
|---|---|---|
|
Mean Cigarettes Smoked Per Day
Study Baseline
|
9.4 Average Cigarettes Smoked Per Day
Standard Deviation 7.7
|
10.1 Average Cigarettes Smoked Per Day
Standard Deviation 7.7
|
|
Mean Cigarettes Smoked Per Day
2 weeks
|
7.2 Average Cigarettes Smoked Per Day
Standard Deviation 9
|
6.7 Average Cigarettes Smoked Per Day
Standard Deviation 6.7
|
|
Mean Cigarettes Smoked Per Day
4 Weeks
|
7.5 Average Cigarettes Smoked Per Day
Standard Deviation 6.6
|
8.2 Average Cigarettes Smoked Per Day
Standard Deviation 8.5
|
|
Mean Cigarettes Smoked Per Day
6 weeks
|
8.1 Average Cigarettes Smoked Per Day
Standard Deviation 8.4
|
7.9 Average Cigarettes Smoked Per Day
Standard Deviation 7.1
|
|
Mean Cigarettes Smoked Per Day
8 weeks
|
8.3 Average Cigarettes Smoked Per Day
Standard Deviation 8.4
|
7.7 Average Cigarettes Smoked Per Day
Standard Deviation 6.5
|
|
Mean Cigarettes Smoked Per Day
12 Weeks
|
8.1 Average Cigarettes Smoked Per Day
Standard Deviation 8.2
|
7.7 Average Cigarettes Smoked Per Day
Standard Deviation 6.3
|
|
Mean Cigarettes Smoked Per Day
16 weeks
|
8.5 Average Cigarettes Smoked Per Day
Standard Deviation 10.8
|
7.8 Average Cigarettes Smoked Per Day
Standard Deviation 7
|
|
Mean Cigarettes Smoked Per Day
26 Weeks
|
8.5 Average Cigarettes Smoked Per Day
Standard Deviation 11.9
|
7.1 Average Cigarettes Smoked Per Day
Standard Deviation 6.5
|
|
Mean Cigarettes Smoked Per Day
21 Weeks
|
9 Average Cigarettes Smoked Per Day
Standard Deviation 11.6
|
7.5 Average Cigarettes Smoked Per Day
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: up to 26 weeks, Baseline, Weeks 2, 4, 6, 8, 12, 16, 21 and 26Population: study population includes all participants that returned for a follow up visit at 2-weeks post intervention or later.
Cigarettes Smoking days were recorded daily and summarized at follow-up visits. The percentage of days since last follow up visit where smoking is recorded is reported
Outcome measures
| Measure |
R-E (Retrieval Extinction)
n=81 Participants
83 anticipated participants will undergo 3 sessions on consecutive days of the Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' smoking-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of smoking-related cues (e.g., pictures). Participants will also receive a lab-based smoking-related cue-reactivity experience during the baseline assessment and 24-hour follow-up test.
|
NR-E (No R-E)
n=82 Participants
83 anticipated participants will undergo 3 sessions on consecutive days of the control Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' non-smoking or neutral-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of non-smoking or neutral cues (e.g., pictures). Participants will also receive a lab-based non-smoking or neutral cue-reactivity experience during the baseline assessment and 24-hour follow-up test.
|
|---|---|---|
|
Percentage of Smoking Days
Study Baseline
|
98.5 percentage of days reported smoking
Standard Deviation 5.3
|
98.1 percentage of days reported smoking
Standard Deviation 10.5
|
|
Percentage of Smoking Days
2 weeks
|
72.5 percentage of days reported smoking
Standard Deviation 37.8
|
70.2 percentage of days reported smoking
Standard Deviation 40
|
|
Percentage of Smoking Days
4 Weeks
|
76.1 percentage of days reported smoking
Standard Deviation 39.2
|
74.7 percentage of days reported smoking
Standard Deviation 39.4
|
|
Percentage of Smoking Days
6 weeks
|
77.1 percentage of days reported smoking
Standard Deviation 38.9
|
73.8 percentage of days reported smoking
Standard Deviation 40
|
|
Percentage of Smoking Days
8 weeks
|
77 percentage of days reported smoking
Standard Deviation 37.5
|
75.1 percentage of days reported smoking
Standard Deviation 39
|
|
Percentage of Smoking Days
12 Weeks
|
73.2 percentage of days reported smoking
Standard Deviation 41.7
|
74 percentage of days reported smoking
Standard Deviation 37.4
|
|
Percentage of Smoking Days
16 weeks
|
68.2 percentage of days reported smoking
Standard Deviation 43.8
|
70.7 percentage of days reported smoking
Standard Deviation 42.5
|
|
Percentage of Smoking Days
21 Weeks
|
64.8 percentage of days reported smoking
Standard Deviation 46.4
|
67.9 percentage of days reported smoking
Standard Deviation 41.6
|
|
Percentage of Smoking Days
26 Weeks
|
62.4 percentage of days reported smoking
Standard Deviation 44.4
|
66.2 percentage of days reported smoking
Standard Deviation 42.7
|
SECONDARY outcome
Timeframe: up to 24 weeks, Baseline, 24 Hours, Weeks 2, 4, 6, 8, 12, and 24Population: Participant included are those randomized to study treatment and return for at least 1 study visit. Mean mood-Craving response and standard deviations to the novel cues are listed.
At each visit (baseline, intervention sessions, and follow-up test sessions), participants will complete a mood craving during each visit. The mood craving form is a single item question ranging from 0 (no craving) to 100 (greatest craving possible). This measure will examine the behavioral response to the novel cue over the course of the study, and differences in response between the R-E arms and NR-E arms.
Outcome measures
| Measure |
R-E (Retrieval Extinction)
n=80 Participants
83 anticipated participants will undergo 3 sessions on consecutive days of the Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' smoking-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of smoking-related cues (e.g., pictures). Participants will also receive a lab-based smoking-related cue-reactivity experience during the baseline assessment and 24-hour follow-up test.
|
NR-E (No R-E)
n=81 Participants
83 anticipated participants will undergo 3 sessions on consecutive days of the control Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' non-smoking or neutral-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of non-smoking or neutral cues (e.g., pictures). Participants will also receive a lab-based non-smoking or neutral cue-reactivity experience during the baseline assessment and 24-hour follow-up test.
|
|---|---|---|
|
Mean Mood-Craving Response to the Novel Cue
Study Baseline
|
62.1 score on a scale, 0-100
Standard Deviation 29.2
|
69.5 score on a scale, 0-100
Standard Deviation 24.2
|
|
Mean Mood-Craving Response to the Novel Cue
24 Hours
|
38.1 score on a scale, 0-100
Standard Deviation 29.7
|
46.5 score on a scale, 0-100
Standard Deviation 29.1
|
|
Mean Mood-Craving Response to the Novel Cue
4 Weeks
|
33.1 score on a scale, 0-100
Standard Deviation 29.6
|
33.4 score on a scale, 0-100
Standard Deviation 31.2
|
|
Mean Mood-Craving Response to the Novel Cue
6 Weeks
|
29.7 score on a scale, 0-100
Standard Deviation 27.4
|
31.1 score on a scale, 0-100
Standard Deviation 29.3
|
|
Mean Mood-Craving Response to the Novel Cue
8 Weeks
|
31.8 score on a scale, 0-100
Standard Deviation 25.1
|
30.5 score on a scale, 0-100
Standard Deviation 29.6
|
|
Mean Mood-Craving Response to the Novel Cue
12 Weeks
|
29.6 score on a scale, 0-100
Standard Deviation 27.6
|
31.3 score on a scale, 0-100
Standard Deviation 29.4
|
|
Mean Mood-Craving Response to the Novel Cue
24 Weeks
|
23.1 score on a scale, 0-100
Standard Deviation 27.1
|
23.3 score on a scale, 0-100
Standard Deviation 29.6
|
|
Mean Mood-Craving Response to the Novel Cue
2 Weeks
|
32.3 score on a scale, 0-100
Standard Deviation 26.5
|
33.5 score on a scale, 0-100
Standard Deviation 31.6
|
Adverse Events
R-E (Retrieval Extinction)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NR-E (No R-E)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Michael Saladin
Medical University of South Carolina
Phone: (843) 792-5306
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place