Trial Outcomes & Findings for Study of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence (NCT NCT01641159)
NCT ID: NCT01641159
Last Updated: 2015-01-07
Results Overview
The primary outcome measure selected for the present two-stage protocol is the maximum days of continuous cocaine abstinence during study weeks 4-15. The Timeline Follow-back (TLFB) procedure (Sobell and Sobell, 1992; Fals-Stewart, 2000) will be used to assess the participants' self-reported use of substances for each day of the study. A rapid UDS system that screens for drugs of abuse will be used to analyze the urine samples.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
study week 16
Results posted on
2015-01-07
Participant Flow
Participant milestones
| Measure |
Buspirone Plus TAU
Buspirone titrated to 60 mg/day for the 15-week active study
Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated.
|
Placebo Plus TAU
Placebo taken daily for the 15-week active study
Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
27
|
|
Overall Study
COMPLETED
|
33
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Buspirone Plus TAU
Buspirone titrated to 60 mg/day for the 15-week active study
Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated.
|
Placebo Plus TAU
Placebo taken daily for the 15-week active study
Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Buspirone Plus TAU
n=35 Participants
Buspirone titrated to 60 mg/day for the 15-week active study
Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated.
|
Placebo Plus TAU
n=27 Participants
Placebo taken daily for the 15-week active study
Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets.
|
Total
n=62 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
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
35 participants
n=5 Participants
|
27 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: study week 16The primary outcome measure selected for the present two-stage protocol is the maximum days of continuous cocaine abstinence during study weeks 4-15. The Timeline Follow-back (TLFB) procedure (Sobell and Sobell, 1992; Fals-Stewart, 2000) will be used to assess the participants' self-reported use of substances for each day of the study. A rapid UDS system that screens for drugs of abuse will be used to analyze the urine samples.
Outcome measures
| Measure |
Buspirone Plus TAU
n=35 Participants
Buspirone titrated to 60 mg/day for the 15-week active study
Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated.
|
Placebo Plus TAU
n=27 Participants
Placebo taken daily for the 15-week active study
Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets.
|
|---|---|---|
|
Maximum Days of Continuous Cocaine Abstinence
|
42.9 Days
Standard Deviation 30.83
|
46.6 Days
Standard Deviation 31.03
|
SECONDARY outcome
Timeframe: study week 16Population: All randomized participants
Cocaine use days during days 22-105 as assessed by UDS and self-report combined with no imputation
Outcome measures
| Measure |
Buspirone Plus TAU
n=35 Participants
Buspirone titrated to 60 mg/day for the 15-week active study
Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated.
|
Placebo Plus TAU
n=27 Participants
Placebo taken daily for the 15-week active study
Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets.
|
|---|---|---|
|
Cocaine-use Days
|
0.153 proportion of cocaine use days
|
0.134 proportion of cocaine use days
|
Adverse Events
Buspirone Plus TAU
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo Plus TAU
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Buspirone Plus TAU
n=35 participants at risk
Buspirone titrated to 60 mg/day for the 15-week active study
Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated.
|
Placebo Plus TAU
n=27 participants at risk
Placebo taken daily for the 15-week active study
Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets.
|
|---|---|---|
|
Infections and infestations
Pulmonary tuberculosis
|
2.9%
1/35 • Number of events 1 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
0.00%
0/27 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Infections and infestations
Pneumonia
|
2.9%
1/35 • Number of events 1 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
0.00%
0/27 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
General disorders
Chest pain
|
2.9%
1/35 • Number of events 1 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
0.00%
0/27 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
Other adverse events
| Measure |
Buspirone Plus TAU
n=35 participants at risk
Buspirone titrated to 60 mg/day for the 15-week active study
Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated.
|
Placebo Plus TAU
n=27 participants at risk
Placebo taken daily for the 15-week active study
Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
42.9%
15/35 • Number of events 18 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
3.7%
1/27 • Number of events 1 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Nervous system disorders
Headache
|
22.9%
8/35 • Number of events 8 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
25.9%
7/27 • Number of events 8 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Nervous system disorders
Somnolence
|
8.6%
3/35 • Number of events 3 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
7.4%
2/27 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Infections and infestations
Nasopharyngitis
|
22.9%
8/35 • Number of events 8 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
14.8%
4/27 • Number of events 6 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
2/35 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
7.4%
2/27 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Infections and infestations
Bronchitis
|
5.7%
2/35 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
3.7%
1/27 • Number of events 1 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Infections and infestations
Influenza
|
8.6%
3/35 • Number of events 3 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
0.00%
0/27 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/35 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
7.4%
2/27 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
22.9%
8/35 • Number of events 11 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
7.4%
2/27 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • Number of events 3 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
7.4%
2/27 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
2/35 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
3.7%
1/27 • Number of events 1 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
2/35 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
3.7%
1/27 • Number of events 1 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/35 • Number of events 1 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
11.1%
3/27 • Number of events 3 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/35 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
11.1%
3/27 • Number of events 3 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.7%
2/35 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
0.00%
0/27 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
5.7%
2/35 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
0.00%
0/27 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
5/35 • Number of events 5 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
7.4%
2/27 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
2/35 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
3.7%
1/27 • Number of events 1 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
2/35 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
3.7%
1/27 • Number of events 1 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/35 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
7.4%
2/27 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Investigations
Weight increased
|
5.7%
2/35 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
3.7%
1/27 • Number of events 1 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
|
Psychiatric disorders
Insomnia
|
5.7%
2/35 • Number of events 2 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
0.00%
0/27 • Between the first dose of study drug and the last dose of study drug plus 7 days, for up to 16 weeks
|
Additional Information
Dr. Theresa Winhusen
University of Cincinnati College of Medicine; Department of Psychiatry
Phone: 513-585-8227
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place