Trial Outcomes & Findings for Study of Treatment for Opioid Dependence and Anxiety Disorders (NCT NCT02252068)
NCT ID: NCT02252068
Last Updated: 2020-11-17
Results Overview
Number of weeks of opioid use at Week 12 for the last 4 weeks of treatment (Weeks 9-12), as assessed by self-report and validated by urine drug screen
COMPLETED
NA
37 participants
Week 12
2020-11-17
Participant Flow
In the randomized controlled trial, 6 participants completed a baseline assessment but dropped out prior to randomization.
Participant milestones
| Measure |
I-CBT Feasibility Pilot
Open trial of I-CBT
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
RCT I-CBT
Randomized controlled trial: Integrated Cognitive-Behavioral Therapy Arm
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
RCT IDC
Randomized Controlled Trial: Individual Drug Counseling Arm
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
13
|
13
|
|
Overall Study
COMPLETED
|
3
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Treatment for Opioid Dependence and Anxiety Disorders
Baseline characteristics by cohort
| Measure |
I-CBT Feasibility Pilot
n=5 Participants
Open trial of I-CBT
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
I-CBT RCT
n=13 Participants
Randomized control trial of I-CBT vs ICD
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
IDC RCT
n=13 Participants
Randomized control trial of I-CBT vs ICD
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.8 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
33.9 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
31.8 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
32.7 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
31 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Due to partial missing data, the analysis population does not reflect the full sample. Specifically, missing data for 2 participants in RCT: I-CBT arm.
Number of weeks of opioid use at Week 12 for the last 4 weeks of treatment (Weeks 9-12), as assessed by self-report and validated by urine drug screen
Outcome measures
| Measure |
I-CBT Feasibility Pilot
n=3 Participants
Open trial of I-CBT
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
RCT: I-CBT
n=11 Participants
Randomized control trial of I-CBT vs ICD
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
RCT IDC
n=13 Participants
Randomized control trial of I-CBT vs ICD
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.
|
|---|---|---|---|
|
Urine-confirmed Self-reported Weeks of Opioid Use
|
1 weeks
Standard Deviation 1.73
|
.36 weeks
Standard Deviation 1.2
|
.31 weeks
Standard Deviation .85
|
PRIMARY outcome
Timeframe: Week 12Population: Due to partial missing data, not all participants are included in this analysis. Specifically, missing data for 1 participant in the RCT: I-CBT arm.
Hamilton Anxiety Rating Scale (HADS) score. Measure assesses the severity of anxiety symptoms. Total scale scores are reported. Higher scores reflect worse outcome. The range of possible scores is 0-56.
Outcome measures
| Measure |
I-CBT Feasibility Pilot
n=3 Participants
Open trial of I-CBT
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
RCT: I-CBT
n=12 Participants
Randomized control trial of I-CBT vs ICD
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
RCT IDC
n=13 Participants
Randomized control trial of I-CBT vs ICD
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.
|
|---|---|---|---|
|
Anxiety Symptom Severity
|
9.3 score on a scale
Standard Deviation 3.1
|
14.5 score on a scale
Standard Deviation 8.2
|
13.0 score on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Week 12Population: Due to partial missing data, not all participants are included in this analysis. Specifically 2 people are missing from the RCT:I-CBT arm and 3 from the RCT IDC arm.
Assessed by the World Health Organization Quality of Life measure, measure reflects overall health as an indicator of quality of life. The scale range of possible scores is 2-10, with higher scores reflected better outcome (i.e., better general health).
Outcome measures
| Measure |
I-CBT Feasibility Pilot
n=3 Participants
Open trial of I-CBT
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
RCT: I-CBT
n=11 Participants
Randomized control trial of I-CBT vs ICD
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
RCT IDC
n=10 Participants
Randomized control trial of I-CBT vs ICD
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.
|
|---|---|---|---|
|
Quality of Life - General Health Score
|
5.7 score on a scale
Standard Deviation 2.9
|
5.9 score on a scale
Standard Deviation 1.2
|
6.8 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Week 12Days of other substance use in the past 30 days
Outcome measures
| Measure |
I-CBT Feasibility Pilot
n=3 Participants
Open trial of I-CBT
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
RCT: I-CBT
n=11 Participants
Randomized control trial of I-CBT vs ICD
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
RCT IDC
n=10 Participants
Randomized control trial of I-CBT vs ICD
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.
|
|---|---|---|---|
|
Non-opioid Substance Use
|
9.3 days
Standard Deviation 16.2
|
4.8 days
Standard Deviation 9.3
|
7.8 days
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: Week 12Population: Due to partial missing data, 2 participants are missing from the RCT ICBT arm and 3 from the RCT IDC arm.
Assessed by the Addiction Severity Index (ASI) Drug Severity Score, this score reflects the severity of functional impairment due to drug use. Higher scores reflect more interference (worse outcome) and the range of scores is 0-1.
Outcome measures
| Measure |
I-CBT Feasibility Pilot
n=3 Participants
Open trial of I-CBT
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
RCT: I-CBT
n=11 Participants
Randomized control trial of I-CBT vs ICD
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
RCT IDC
n=10 Participants
Randomized control trial of I-CBT vs ICD
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.
|
|---|---|---|---|
|
Functional Impairment
|
.15 score on a scale
Standard Deviation .14
|
.10 score on a scale
Standard Deviation .10
|
.07 score on a scale
Standard Deviation .05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Due to partial missing data, 2 participants are missing from the RCT ICBT arm and 2 from the RCT IDC arm.
Assessed by the Client Satisfaction Questionnaire (CSQ), this measure assesses patient satisfaction with treatment. Higher scores reflect higher satisfaction (better outcome). The scores range from 8-32.
Outcome measures
| Measure |
I-CBT Feasibility Pilot
n=3 Participants
Open trial of I-CBT
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
RCT: I-CBT
n=11 Participants
Randomized control trial of I-CBT vs ICD
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
|
RCT IDC
n=11 Participants
Randomized control trial of I-CBT vs ICD
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.
|
|---|---|---|---|
|
Patient Satisfaction
|
32 score on a scale
Standard Deviation 0
|
26.9 score on a scale
Standard Deviation 4.8
|
29.4 score on a scale
Standard Deviation 3.2
|
Adverse Events
I-CBT Feasibility Pilot
RCT I-CBT
RCT IDC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place