Trial Outcomes & Findings for Pharmacotherapy & CM for Opioid and Cocaine Dependence (NCT NCT00838981)
NCT ID: NCT00838981
Last Updated: 2021-12-03
Results Overview
thrice weekly urine tests
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
91 participants
Primary outcome timeframe
up to 12 weeks.
Results posted on
2021-12-03
Participant Flow
Adult male and female participants were recruited from the Greater New Haven area from May 2008 to March 2014 by word-of-mouth, flyers and from referrals from treatment centers in the local area. The study was conducted in an outpatient clinic of the West Haven VA Hospital.
After eligibility was determined, participants were randomized to placebo, 200mg up to 400mg of modafinil.The study consisted of three phases that involve: 1) a one or two week "induction" phase, 2) an eleven-week "treatment" phase; and 3) a four week "taper, detoxification or transfer" phase.
Participant milestones
| Measure |
Modafinil Plus Contingency Management
Modafinil from 200mg up to 400mg
Modafinil: Modafinil will be phase in from 200mg to 400mg
|
Modafinil Plus Voucher Control
Modafinil from 200mg up to 400mg plus the voucher control
|
Placebo Plus Voucher Control
Sugar pill plus voucher control
|
Placebo Plus Contingency Management
Sugar pill plus contingency management
|
|---|---|---|---|---|
|
Week 1 Days 1-3
STARTED
|
26
|
19
|
27
|
19
|
|
Week 1 Days 1-3
COMPLETED
|
26
|
19
|
27
|
19
|
|
Week 1 Days 1-3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Day 4 to Week 11
STARTED
|
26
|
19
|
27
|
19
|
|
Day 4 to Week 11
Completed Main Treatment on 400mg
|
22
|
13
|
17
|
14
|
|
Day 4 to Week 11
COMPLETED
|
19
|
11
|
16
|
12
|
|
Day 4 to Week 11
NOT COMPLETED
|
7
|
8
|
11
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacotherapy & CM for Opioid and Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Modafinil Plus CM
n=26 Participants
Modafinil from 200mg up to 400mg
Modafinil: Modafinil will be phase in from 200mg to 400mg
|
Modafinil Plus Voucher Control
n=19 Participants
Modafinil from 200mg up to 400mg
Modafinil: Modafinil will be phase in from 200mg to 400mg
|
Sugar Pill Plus CM
n=19 Participants
Placebo: sugar pill
Sugar Pill: placebo, sugar pill will mirror active drug
|
Sugar Pill Plus Voucher Control
n=27 Participants
Placebo: sugar pill
Sugar Pill: placebo, sugar pill will mirror active drug
|
Total
n=91 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
41.5 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
34.5 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
38.2 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
38.3 years
STANDARD_DEVIATION 10.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
27 participants
n=4 Participants
|
91 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeks.thrice weekly urine tests
Outcome measures
| Measure |
Modafinil Plus Contingency Magagement
n=26 Participants
Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.
Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample.
|
Sugar Pill Plus Contingency Management
n=19 Participants
Placebo: sugar pill
Sugar Pill: placebo, sugar pill will mirror active drug
Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample.
|
Modafinil Plus Voucher Control
n=19 Participants
Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.
Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that the
|
Sugar Pill Plus Voucher Control
n=25 Participants
Sugar Pill: placebo, sugar pill will mirror active drug
Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will b
|
|---|---|---|---|---|
|
Average Number of Positive Urine Tests
Total Tests
|
32 urine tests
Standard Deviation 8.4
|
30.2 urine tests
Standard Deviation 8.6
|
28.1 urine tests
Standard Deviation 11.2
|
31.4 urine tests
Standard Deviation 7.1
|
|
Average Number of Positive Urine Tests
Cocaine
|
17.5 urine tests
Standard Deviation 13.6
|
16.1 urine tests
Standard Deviation 11.4
|
16.9 urine tests
Standard Deviation 10.7
|
15.8 urine tests
Standard Deviation 11.8
|
|
Average Number of Positive Urine Tests
Heroine
|
16.9 urine tests
Standard Deviation 13.4
|
11.9 urine tests
Standard Deviation 10.7
|
12.3 urine tests
Standard Deviation 11.1
|
14 urine tests
Standard Deviation 13.6
|
|
Average Number of Positive Urine Tests
Any opiate
|
17.7 urine tests
Standard Deviation 13.6
|
12.3 urine tests
Standard Deviation 10.6
|
12.5 urine tests
Standard Deviation 11.1
|
14.3 urine tests
Standard Deviation 13.7
|
PRIMARY outcome
Timeframe: up to 84 daysOutcome measures
| Measure |
Modafinil Plus Contingency Magagement
n=25 Participants
Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.
Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample.
|
Sugar Pill Plus Contingency Management
n=19 Participants
Placebo: sugar pill
Sugar Pill: placebo, sugar pill will mirror active drug
Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample.
|
Modafinil Plus Voucher Control
n=17 Participants
Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.
Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that the
|
Sugar Pill Plus Voucher Control
n=23 Participants
Sugar Pill: placebo, sugar pill will mirror active drug
Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will b
|
|---|---|---|---|---|
|
Average Maximum Days Abstinent
Alcohol
|
69 days
Standard Deviation 21
|
58.3 days
Standard Deviation 26.4
|
67.2 days
Standard Deviation 21.9
|
71.8 days
Standard Deviation 19.6
|
|
Average Maximum Days Abstinent
Cocaine
|
30.9 days
Standard Deviation 28.2
|
32.7 days
Standard Deviation 24.2
|
24.4 days
Standard Deviation 23.3
|
34.7 days
Standard Deviation 32.1
|
|
Average Maximum Days Abstinent
Heroine
|
40.7 days
Standard Deviation 30.3
|
46.2 days
Standard Deviation 31.1
|
47.6 days
Standard Deviation 33.4
|
48.4 days
Standard Deviation 33.2
|
|
Average Maximum Days Abstinent
Any opiate
|
31.7 days
Standard Deviation 28
|
37.4 days
Standard Deviation 27.8
|
43.5 days
Standard Deviation 31.3
|
41.4 days
Standard Deviation 32.6
|
SECONDARY outcome
Timeframe: up to 90 daysOutcome measures
| Measure |
Modafinil Plus Contingency Magagement
n=25 Participants
Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.
Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample.
|
Sugar Pill Plus Contingency Management
n=19 Participants
Placebo: sugar pill
Sugar Pill: placebo, sugar pill will mirror active drug
Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample.
|
Modafinil Plus Voucher Control
n=17 Participants
Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.
Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that the
|
Sugar Pill Plus Voucher Control
n=23 Participants
Sugar Pill: placebo, sugar pill will mirror active drug
Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will b
|
|---|---|---|---|---|
|
Average Number of Days Using a Substance Within Treatment
Alcohol
|
0.32 days
Standard Deviation .9
|
1.8 days
Standard Deviation 5.2
|
0.06 days
Standard Deviation 0.24
|
0.13 days
Standard Deviation 0.34
|
|
Average Number of Days Using a Substance Within Treatment
Cocaine
|
19 days
Standard Deviation 19.1
|
15.6 days
Standard Deviation 15.7
|
18.6 days
Standard Deviation 14.3
|
20.3 days
Standard Deviation 20.2
|
|
Average Number of Days Using a Substance Within Treatment
Heroin
|
13.8 days
Standard Deviation 23.4
|
11.4 days
Standard Deviation 17.6
|
10.2 days
Standard Deviation 15.6
|
11.7 days
Standard Deviation 18.7
|
|
Average Number of Days Using a Substance Within Treatment
Opiate
|
21.8 days
Standard Deviation 26
|
13.4 days
Standard Deviation 16.8
|
11.9 days
Standard Deviation 16
|
16.4 days
Standard Deviation 23.1
|
Adverse Events
Modafinil Plus Contingency Magagement
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Sugar Pill Plus Contingency Management
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Modafinil Plus Voucher Control
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Sugar Pill Plus Voucher Control
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Modafinil Plus Contingency Magagement
n=26 participants at risk
Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.
Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample.
|
Sugar Pill Plus Contingency Management
n=19 participants at risk
Placebo: sugar pill
Sugar Pill: placebo, sugar pill will mirror active drug
Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample.
|
Modafinil Plus Voucher Control
n=19 participants at risk
Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.
Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that the
|
Sugar Pill Plus Voucher Control
n=27 participants at risk
Sugar Pill: placebo, sugar pill will mirror active drug
Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will b
|
|---|---|---|---|---|
|
Psychiatric disorders
Disturbed concentration
|
11.5%
3/26 • 12 weeks
|
10.5%
2/19 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
|
Psychiatric disorders
Agitation
|
15.4%
4/26 • 12 weeks
|
31.6%
6/19 • 12 weeks
|
15.8%
3/19 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
|
General disorders
Tired
|
38.5%
10/26 • 12 weeks
|
31.6%
6/19 • 12 weeks
|
26.3%
5/19 • 12 weeks
|
18.5%
5/27 • 12 weeks
|
|
General disorders
Drowsy
|
26.9%
7/26 • 12 weeks
|
15.8%
3/19 • 12 weeks
|
10.5%
2/19 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
|
General disorders
Insomnia
|
34.6%
9/26 • 12 weeks
|
10.5%
2/19 • 12 weeks
|
21.1%
4/19 • 12 weeks
|
18.5%
5/27 • 12 weeks
|
|
General disorders
Nightmare
|
7.7%
2/26 • 12 weeks
|
21.1%
4/19 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
22.2%
6/27 • 12 weeks
|
|
General disorders
Depression
|
34.6%
9/26 • 12 weeks
|
21.1%
4/19 • 12 weeks
|
21.1%
4/19 • 12 weeks
|
14.8%
4/27 • 12 weeks
|
|
Psychiatric disorders
anxiety
|
30.8%
8/26 • 12 weeks
|
21.1%
4/19 • 12 weeks
|
26.3%
5/19 • 12 weeks
|
7.4%
2/27 • 12 weeks
|
|
Nervous system disorders
Numbness
|
19.2%
5/26 • 12 weeks
|
21.1%
4/19 • 12 weeks
|
10.5%
2/19 • 12 weeks
|
7.4%
2/27 • 12 weeks
|
|
General disorders
Headache
|
23.1%
6/26 • 12 weeks
|
15.8%
3/19 • 12 weeks
|
21.1%
4/19 • 12 weeks
|
22.2%
6/27 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
42.3%
11/26 • 12 weeks
|
42.1%
8/19 • 12 weeks
|
15.8%
3/19 • 12 weeks
|
11.1%
3/27 • 12 weeks
|
|
Gastrointestinal disorders
Decreased Appetite
|
15.4%
4/26 • 12 weeks
|
15.8%
3/19 • 12 weeks
|
5.3%
1/19 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place