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Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)
NA trial testing Nicotine Patch in Cigarette Smoking in 87 participants. Completed in 8 September 2017.
| Lead sponsor | Francis McClernon, Ph.D. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 87 |
| Start date | 8 October 2015 |
| Primary completion | 8 September 2017 |
| Estimated completion | 8 September 2017 |
| Sites | 1 location across United States |
Francis McClernon, Ph.D. — full company profile →
Adults 18 to 65, any sex, with Cigarette Smoking. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Effects of MCE+ (vs. MCE-) on pre-quit nicotine dependence. The score of the questionnaire ranges in value from 0 (not at all dependent) to 10 (highly dependent).
| Group | Value | 95% CI |
|---|---|---|
| MCE+ | .67 | ± 2.61 |
| MCE- (Control) | 1.33 | ± 1.35 |
Effects of MCE+ (vs. MCE-) on smoking cessation outcomes. Relapse is defined as 7 consecutive days of smoking. Outcome reported as number of participants who met relapse definition.
| Group | Value | 95% CI |
|---|---|---|
| MCE+ | 9 | |
| MCE- (Control) | 11 |
Compliance with smoking VLNCs. Reduction in usual brand (UB) cigarette use over the treatment period will be calculated for each group. Average usual brand cigarettes per day was calculated using the average number for the first 5 days of treatment (week 1) and the average number for the last 5 days of treatment (week 6). Values were calculated as number smoked at W1 minus the number smoked at W6.
| Group | Value | 95% CI |
|---|---|---|
| MCE+ | 0 | ± 0 |
| MCE- (Control) | -1.32 | ± 4.56 |
Reduction in total cigarette use over the treatment period will be calculated for each group. Average cigarettes per day was calculated using the average number for the 5 days leading up to week 3 and the average number for the 5 days leading up to week 6. Values were calculated as number smoked at W3 minus the number smoked at W6. Positive values represent a decrease in smoking behavior.
| Group | Value | 95% CI |
|---|---|---|
| MCE+ | 3.05 | ± 5.34 |
| MCE- (Control) | -.35 | ± 9.55 |
Craving score across MCE sessions. Scores range from 0 (no craving) to 100 (extreme craving)
| Group | Value | 95% CI |
|---|---|---|
| MCE+ | 14.58 | ± 24.12 |
| MCE- (Control) | 0.98 | ± 2.09 |
| Group | Value | 95% CI |
|---|---|---|
| MCE+ | 11.88 | ± 19.67 |
| MCE- (Control) | 4.29 | ± 10.15 |
| Group | Value | 95% CI |
|---|---|---|
| MCE+ | 8.25 | ± 12.25 |
| MCE- (Control) | 1.34 | ± 2.84 |
Difference in craving responses. Craving at each time point was measured on a scale from 0 (no craving) to 100 (strong craving). Value reported represents difference in baseline - week 6.
| Group | Value | 95% CI |
|---|---|---|
| MCE+ | 23.2 | ± 26.3 |
| MCE- (Control) | 15.2 | ± 21.0 |
Time frame: Adverse events were collected at each study visit during participation (approximately 16 weeks).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | MCE+ | MCE- (Control) |
|---|---|---|---|
| hypertension | Vascular disorders | — | — |
| Reaction | System | MCE+ | MCE- (Control) |
|---|---|---|---|
| Vivid Dreams | General disorders | — | — |
| Irritability | General disorders | — | — |
| Patch, Itching or burning at patch site | Skin and subcutaneous tissue disorders | — | — |
| Patch, Rash at patch site | Skin and subcutaneous tissue disorders | — | — |
| Depression | Psychiatric disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Headache, Non-migraine | Nervous system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Nightmare | Psychiatric disorders | — | — |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Pain, Musculoskeletal | Musculoskeletal and connective tissue disorders | — | — |
| Stress | Social circumstances | — | — |
| Fatigue | General disorders | — | — |
| tachycardia | Cardiac disorders | — | — |
| vomiting | Gastrointestinal disorders | — | — |
| depressed mood | Psychiatric disorders | — | — |
| Mouth/throat irritation | Respiratory, thoracic and mediastinal disorders | — | — |
| Fever | General disorders | — | — |
| GERD | Gastrointestinal disorders | — | — |
| Headache, Migraine | Nervous system disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Nasal sinus drainage | Respiratory, thoracic and mediastinal disorders | — | — |
| sore throat | Respiratory, thoracic and mediastinal disorders | — | — |
| Dental, Teeth | Nervous system disorders | — | — |
| Tonsilitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Allergies | Respiratory, thoracic and mediastinal disorders | — | — |
| Body aches | Musculoskeletal and connective tissue disorders | — | — |
| bone fracture | Musculoskeletal and connective tissue disorders | — | — |
| bronchitis | Respiratory, thoracic and mediastinal disorders | — | — |
| constipation | Gastrointestinal disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Increased appetite | Metabolism and nutrition disorders | — | — |
| Mania | Psychiatric disorders | — | — |
| Menstrual cramps | Reproductive system and breast disorders | — | — |
| Pain, Arthritis | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: hypertension.
Data from ClinicalTrials.gov NCT02538042 adverse events section.
The central objective of the project is to evaluate the effect of incorporating smoking related contexts into very low nicotine content (VLNC) cigarette extinction trials on clinically relevant, smoking-related outcomes. Adult smokers interested in quitting smoking (N=80) will be interviewed and trained to take pictures where they smoke cigarettes. Following taking these pictures, participants will then be switched to smoke VLNCs while wearing a 21 mg/d nicotine patch (EXT) for three weeks. During this 3-week treatment period, half of the sample (n=40) will be randomly assigned to undergo six, 60-minute sessions of multiple context extinction (MCE+) during which they will view smoking-related environments and smoke their assigned cigarettes. The remaining 40 participants will undergo control MCE (exposure to nature environments; MCE-) and smoke their assigned cigarettes. At the end of the three weeks, participants will quit smoking and continue to wear the nicotine patch while being followed during a 10-week abstinence period. Participants will also complete a follow-up phone call 6 months after their quit day.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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