Trial Outcomes & Findings for Behavioral Treatment of Adolescent Substance Use (NCT NCT02063984)
NCT ID: NCT02063984
Last Updated: 2021-06-04
Results Overview
Number of participants with any cannabis abstinence during treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
Intervention weeks 1 to 14
Results posted on
2021-06-04
Participant Flow
Recruited from a community intensive outpatient program from December 2015 to October 2017.
Participant milestones
| Measure |
CM + WMT
Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)
|
CM + No WMT
Intensive Outpatient Treatment + Contingency Management (IOP + CM)
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
CM + WMT
Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)
|
CM + No WMT
Intensive Outpatient Treatment + Contingency Management (IOP + CM)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
Baseline Characteristics
Behavioral Treatment of Adolescent Substance Use
Baseline characteristics by cohort
| Measure |
CM + WMT
n=29 Participants
Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)
|
CM + No WMT
n=30 Participants
Intensive Outpatient Treatment + Contingency Management (IOP + CM)
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.0 years
STANDARD_DEVIATION 1.5 • n=99 Participants
|
16.7 years
STANDARD_DEVIATION 2.1 • n=107 Participants
|
16.35 years
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
30 participants
n=107 Participants
|
59 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Intervention weeks 1 to 14Population: Participants who met Cannabis Use Disorder criteria, excluding those who met other drug use disorder criteria.
Number of participants with any cannabis abstinence during treatment
Outcome measures
| Measure |
CM + WMT
n=29 Participants
Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)
|
CM + No WMT
n=30 Participants
Intensive Outpatient Treatment + Contingency Management (IOP + CM)
|
Strategy 3
Start in CM responders stay in CM, non-responders get Enhanced CM
|
Strategy 4
Start in CM+WMT responders stay in CM+WMT, non-responders get Enhanced CM+WMT
|
|---|---|---|---|---|
|
Any Cannabis Abstinence
|
13 participants
|
18 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 14 week treatment periodPopulation: Calculated only for those who achieved at least one week of abstinence during the treatment period
Weeks of continuous abstinence during treatment
Outcome measures
| Measure |
CM + WMT
n=13 Participants
Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)
|
CM + No WMT
n=18 Participants
Intensive Outpatient Treatment + Contingency Management (IOP + CM)
|
Strategy 3
Start in CM responders stay in CM, non-responders get Enhanced CM
|
Strategy 4
Start in CM+WMT responders stay in CM+WMT, non-responders get Enhanced CM+WMT
|
|---|---|---|---|---|
|
Weeks of Continuous Cannabis Abstinence
|
7.15 Weeks of Continuous Abstinence
Standard Deviation 4.63
|
4.88 Weeks of Continuous Abstinence
Standard Deviation 4.35
|
—
|
—
|
SECONDARY outcome
Timeframe: Intervention weeks 1 to 14Population: Participants with Cannabis Use Disorder and with non-missing data on 25% or more of treatment days (excluding those with other drug use disorder)
Number of participants with any days of cannabis use during treatment
Outcome measures
| Measure |
CM + WMT
n=18 Participants
Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)
|
CM + No WMT
n=19 Participants
Intensive Outpatient Treatment + Contingency Management (IOP + CM)
|
Strategy 3
Start in CM responders stay in CM, non-responders get Enhanced CM
|
Strategy 4
Start in CM+WMT responders stay in CM+WMT, non-responders get Enhanced CM+WMT
|
|---|---|---|---|---|
|
Any Days of Cannabis Use
|
11 Participants
|
14 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: The intervention period between Week 1 and Week 14Percent of Days Used During the Treatment Period
Outcome measures
| Measure |
CM + WMT
n=11 Participants
Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)
|
CM + No WMT
n=14 Participants
Intensive Outpatient Treatment + Contingency Management (IOP + CM)
|
Strategy 3
Start in CM responders stay in CM, non-responders get Enhanced CM
|
Strategy 4
Start in CM+WMT responders stay in CM+WMT, non-responders get Enhanced CM+WMT
|
|---|---|---|---|---|
|
Days of Cannabis Use
|
32.5 percentage of days of cannabis use
Standard Deviation 31.0
|
24.5 percentage of days of cannabis use
Standard Deviation 23.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Treatment period between week 1 and week 14Population: Ns in each strategy are the sum of \[1\] dropouts in the phase 1 condition, \[2\] responders in the phase 1 condition; and \[3\] nonresponders in the phase 1 condition who are assigned to the specified phase 2 condition. These ns for each strategy are: \[1\] 5+8+8=21; \[2\] 6+10+5=21; \[3\] 5+8+8=21; \[4\] 6+10+8=24.
Number of participants who achieved at least one week of abstinence
Outcome measures
| Measure |
CM + WMT
n=21 Participants
Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)
|
CM + No WMT
n=21 Participants
Intensive Outpatient Treatment + Contingency Management (IOP + CM)
|
Strategy 3
n=21 Participants
Start in CM responders stay in CM, non-responders get Enhanced CM
|
Strategy 4
n=24 Participants
Start in CM+WMT responders stay in CM+WMT, non-responders get Enhanced CM+WMT
|
|---|---|---|---|---|
|
Any Cannabis Abstinence Across Four Treatment Strategies
|
12 Participants
|
12 Participants
|
14 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Treatment period between week 1 and week 14Population: Participants with at least one week of cannabis abstinence during treatment
Mean weeks of continuous cannabis abstinence among those who achieved at least one week of abstinence
Outcome measures
| Measure |
CM + WMT
n=12 Participants
Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT)
|
CM + No WMT
n=12 Participants
Intensive Outpatient Treatment + Contingency Management (IOP + CM)
|
Strategy 3
n=14 Participants
Start in CM responders stay in CM, non-responders get Enhanced CM
|
Strategy 4
n=11 Participants
Start in CM+WMT responders stay in CM+WMT, non-responders get Enhanced CM+WMT
|
|---|---|---|---|---|
|
Weeks of Cannabis Abstinence Across Four Treatment Strategies
|
6.17 weeks of continuous abstinence
Standard Deviation 4.73
|
7.42 weeks of continuous abstinence
Standard Deviation 4.74
|
5.29 weeks of continuous abstinence
Standard Deviation 4.43
|
7.82 weeks of continuous abstinence
Standard Deviation 4.75
|
Adverse Events
Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 2 deaths
IOP + CM
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 |
Intensive Outpatient Treatment (IOP) + Contingency Management (CM) + Working Memory Training (WMT)
n=29 participants at risk
IOP + CM + WMT
Intensive Outpatient Treatment (IOP) + Contingency Management (CM): Multiple group sessions weekly, one individual counseling session weekly with teen to review and discuss contingency management abstinence-based incentives
Working Memory Training: 25 computer-delivered sessions of neurocognitive training
|
IOP + CM
n=30 participants at risk
IOP + CM
Intensive Outpatient Treatment (IOP) + Contingency Management (CM): Multiple group sessions weekly, one individual counseling session weekly with teen to review and discuss contingency management abstinence-based incentives
|
|---|---|---|
|
Psychiatric disorders
Overdose
|
6.9%
2/29 • Number of events 2 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
0.00%
0/30 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
|
Psychiatric disorders
Suicidal ideation without a plan
|
0.00%
0/29 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
3.3%
1/30 • Number of events 1 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
|
Psychiatric disorders
Suicide attempt
|
3.4%
1/29 • Number of events 1 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
0.00%
0/30 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
|
Social circumstances
Incarceration
|
10.3%
3/29 • Number of events 3 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
13.3%
4/30 • Number of events 4 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
|
Social circumstances
Arrest
|
3.4%
1/29 • Number of events 1 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
0.00%
0/30 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
1/29 • Number of events 1 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
0.00%
0/30 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
|
Psychiatric disorders
Drug induced psychosis
|
0.00%
0/29 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
3.3%
1/30 • Number of events 1 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/29 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
3.3%
1/30 • Number of events 1 • Information will be collected from the scheduled first study visit through the 12 month follow-up assessment visit. (12 months total)
|
Additional Information
Alan J. Budney, Ph.D
Geisel School of Medicine at Dartmouth Center for Technology and Behavioral Health
Phone: 603-646-7088
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place