Trial Outcomes & Findings for Minocycline and Tobacco Craving in Smokers With Schizophrenia (NCT NCT02968602)
NCT ID: NCT02968602
Last Updated: 2022-01-06
Results Overview
This is a 10-item assessment used to measure craving to smoke and used in studies of smokers with schizophrenia. This scale has a score range from 0-100The change in QSU-Brief craving scores between time points (baseline to week 1, and baseline to week 2) will be assessed. The change in scores between the two timepoints will be calculated. The higher the score the stronger the urge to smoke is.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
Baseline, Week 1, and Week 2
Results posted on
2022-01-06
Participant Flow
Participant milestones
| Measure |
Minocycline
Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.
Minocycline: Minocycline capsules taken twice daily for two weeks.
|
Placebo
Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.
Placebo: Placebo capsules taken twice daily for two weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Minocycline and Tobacco Craving in Smokers With Schizophrenia
Baseline characteristics by cohort
| Measure |
Minocycline
n=16 Participants
Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.
Minocycline: Minocycline capsules taken twice daily for two weeks.
|
Placebo
n=16 Participants
Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.
Placebo: Placebo capsules taken twice daily for two weeks.
|
Total
n=32 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
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.43 years
STANDARD_DEVIATION 11.32 • n=5 Participants
|
43.38 years
STANDARD_DEVIATION 8.22 • n=7 Participants
|
43.4 years
STANDARD_DEVIATION 9.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 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
|
0 Participants
n=7 Participants
|
0 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 1, and Week 2This is a 10-item assessment used to measure craving to smoke and used in studies of smokers with schizophrenia. This scale has a score range from 0-100The change in QSU-Brief craving scores between time points (baseline to week 1, and baseline to week 2) will be assessed. The change in scores between the two timepoints will be calculated. The higher the score the stronger the urge to smoke is.
Outcome measures
| Measure |
Minocycline
n=16 Participants
Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.
Minocycline: Minocycline capsules taken twice daily for two weeks.
|
Placebo
n=16 Participants
Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.
Placebo: Placebo capsules taken twice daily for two weeks.
|
|---|---|---|
|
Questionnaire for Smoking Urges-Brief
Baseline to week 1
|
42.1429 score on a scale
Standard Deviation 16.23319
|
38.6429 score on a scale
Standard Deviation 18.46663
|
|
Questionnaire for Smoking Urges-Brief
Baseline to week 2 (Endpoint)
|
43.4286 score on a scale
Standard Deviation 18.03720
|
36.8571 score on a scale
Standard Deviation 17.81467
|
Adverse Events
Minocycline
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Minocycline
n=16 participants at risk
Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.
Minocycline: Minocycline capsules taken twice daily for two weeks.
|
Placebo
n=16 participants at risk
Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.
Placebo: Placebo capsules taken twice daily for two weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • 2 weeks
|
6.2%
1/16 • Number of events 1 • 2 weeks
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Number of events 2 • 2 weeks
|
0.00%
0/16 • 2 weeks
|
|
General disorders
Arthritus
|
6.2%
1/16 • Number of events 1 • 2 weeks
|
0.00%
0/16 • 2 weeks
|
|
General disorders
Hypersalavation
|
0.00%
0/16 • 2 weeks
|
12.5%
2/16 • Number of events 5 • 2 weeks
|
|
General disorders
Sedation
|
12.5%
2/16 • Number of events 2 • 2 weeks
|
18.8%
3/16 • Number of events 3 • 2 weeks
|
|
General disorders
Restlessness
|
12.5%
2/16 • Number of events 3 • 2 weeks
|
0.00%
0/16 • 2 weeks
|
|
General disorders
Loss of Appetite
|
12.5%
2/16 • Number of events 2 • 2 weeks
|
0.00%
0/16 • 2 weeks
|
|
General disorders
Insomnia
|
12.5%
2/16 • Number of events 2 • 2 weeks
|
0.00%
0/16 • 2 weeks
|
|
General disorders
Malaise
|
12.5%
2/16 • Number of events 2 • 2 weeks
|
0.00%
0/16 • 2 weeks
|
|
General disorders
Dizziness
|
12.5%
2/16 • Number of events 2 • 2 weeks
|
0.00%
0/16 • 2 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • 2 weeks
|
6.2%
1/16 • Number of events 1 • 2 weeks
|
|
General disorders
Stiffness
|
6.2%
1/16 • Number of events 1 • 2 weeks
|
0.00%
0/16 • 2 weeks
|
|
General disorders
Uticaria
|
6.2%
1/16 • Number of events 1 • 2 weeks
|
0.00%
0/16 • 2 weeks
|
|
General disorders
Somatic Concern
|
0.00%
0/16 • 2 weeks
|
6.2%
1/16 • Number of events 1 • 2 weeks
|
|
General disorders
Back Pain
|
0.00%
0/16 • 2 weeks
|
6.2%
1/16 • Number of events 1 • 2 weeks
|
|
General disorders
Headache
|
6.2%
1/16 • Number of events 1 • 2 weeks
|
0.00%
0/16 • 2 weeks
|
|
General disorders
Hostility
|
6.2%
1/16 • Number of events 1 • 2 weeks
|
0.00%
0/16 • 2 weeks
|
|
General disorders
Tremor
|
6.2%
1/16 • Number of events 1 • 2 weeks
|
0.00%
0/16 • 2 weeks
|
|
General disorders
"Zoning out"
|
0.00%
0/16 • 2 weeks
|
6.2%
1/16 • Number of events 1 • 2 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place