Trial Outcomes & Findings for Pilot of Mindfulness Oriented Recovery Enhancement in MethadoneTreatment (NCT NCT03894501)

NCT ID: NCT03894501

Last Updated: 2022-01-11

Results Overview

The number of individuals who express interest in the study.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Baseline

Results posted on

2022-01-11

Participant Flow

Participant milestones

Participant milestones
Measure
Mindfulness Oriented Recovery Enhancement
The Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Overall Study
STARTED
15
15
Overall Study
COMPLETED
15
15
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot of Mindfulness Oriented Recovery Enhancement in MethadoneTreatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mindfulness Oriented Recovery Enhancement
n=15 Participants
The Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
Methadone Program Behavioral Treatment as Usual
n=15 Participants
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Total
n=30 Participants
Total of all reporting groups
Age, Continuous
47.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
52.9 years
STANDARD_DEVIATION 8.4 • n=7 Participants
50.4 years
STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
7 Participants
n=7 Participants
15 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
8 Participants
n=7 Participants
15 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
n=5 Participants
12 Participants
n=7 Participants
24 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
7 Participants
n=5 Participants
9 Participants
n=7 Participants
16 Participants
n=5 Participants
Race (NIH/OMB)
White
7 Participants
n=5 Participants
4 Participants
n=7 Participants
11 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Region of Enrollment
United States
15 participants
n=5 Participants
15 participants
n=7 Participants
15 participants
n=5 Participants
Days of Illicit Drug Use
24.0 days
STANDARD_DEVIATION 17.4 • n=5 Participants
25.2 days
STANDARD_DEVIATION 29.3 • n=7 Participants
24.6 days
STANDARD_DEVIATION 23.7 • n=5 Participants
Days of Illicit Opioid Use
6.4 days
STANDARD_DEVIATION 9.2 • n=5 Participants
11.7 days
STANDARD_DEVIATION 12.8 • n=7 Participants
9.1 days
STANDARD_DEVIATION 11.3 • n=5 Participants
Pain Level
28.3 score on a scale
STANDARD_DEVIATION 27.6 • n=5 Participants
37.5 score on a scale
STANDARD_DEVIATION 23.5 • n=7 Participants
32.9 score on a scale
STANDARD_DEVIATION 25.6 • n=5 Participants
Depression Level
27.2 score on a scale
STANDARD_DEVIATION 15.3 • n=5 Participants
23.5 score on a scale
STANDARD_DEVIATION 13.4 • n=7 Participants
25.4 score on a scale
STANDARD_DEVIATION 14.2 • n=5 Participants
Anxiety Level.
41.7 score on a scale
STANDARD_DEVIATION 14.5 • n=5 Participants
39.7 score on a scale
STANDARD_DEVIATION 12.3 • n=7 Participants
40.7 score on a scale
STANDARD_DEVIATION 13.2 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Methadone clinic clients.

The number of individuals who express interest in the study.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=32 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Study Interest
32 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Individuals who expressed interest in the study.

The number of individuals who who refuse participation when offered.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=32 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Study Refusal
2 Participants

PRIMARY outcome

Timeframe: Baseline (study enrollment)

Population: Individuals screened for eligibility.

The number of individuals screened and eligible/ineligible.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=32 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Individuals Screened
0 Participants

PRIMARY outcome

Timeframe: Baseline (study enrollment)

Population: Eligible individuals.

The number of individuals consented.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=32 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Individuals Consented.
31 Participants

PRIMARY outcome

Timeframe: Enrollment

Population: Individuals who participated in consent process.

The number of individuals who refuse participation after/during consent process.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=31 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Refusal After/During Consent Process.
1 Participants

PRIMARY outcome

Timeframe: At 8-weeks (post treatment period completion).

Population: Participants randomized to receive the MORE intervention.

The mean number of sessions completed by study participants in the MORE intervention.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Mean Sessions Completed
6.4 number of sessions
Standard Deviation 3.9

PRIMARY outcome

Timeframe: At 8-weeks (post treatment period completion).

Population: Participants randomized to MORE

The mean percentage of sessions completed by study participants randomized to MORE.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Percentage of Sessions Completed
76 percentage of sessions
Standard Deviation .20

PRIMARY outcome

Timeframe: At 16 weeks.

Population: Participants enrolled and randomized.

Number of participants who drop out of the study.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Number Who Drop Out
0 Participants

PRIMARY outcome

Timeframe: At 16 weeks.

Population: Participants enrolled and randomized.

Percentage of participants who drop out of the study.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Percentage Who Drop Out
0 percentage of particpants

PRIMARY outcome

Timeframe: At baseline,

Population: All randomized participants.

The number of participants who complete baseline assessments.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Baselines Completed
30 Participants

PRIMARY outcome

Timeframe: At baseline,

Population: All randomized participants.

Percentage of people who completed baseline assessments.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Percentage Baselines Completed
100 percentage of baseline assessments

PRIMARY outcome

Timeframe: At 8-weeks.

Population: All participants randomized.

The number of participants who complete 8-week assessments.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
8-weeks Completed
30 Participants

PRIMARY outcome

Timeframe: At 8-weeks.

Population: All randomized participants.

Percentage of participants who completed 8-week assessments.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Percentage 8-Weeks Completed
100 percentage of 8-week assessments.

PRIMARY outcome

Timeframe: At 16-weeks.

Population: All randomized participants.

The number of participants who completed 16-week assessments.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
16-Weeks Completed
29 Participants

PRIMARY outcome

Timeframe: At 16-weeks.

Population: All randomized participants.

Percentage of participants who completed 16-week assessments.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Percentage of 16-Weeks Completed
96.7 percentage of 16-week assessments.

SECONDARY outcome

Timeframe: 16-weeks

Population: All individuals randomized.

Research staff asked participants if they used various drugs (i.e., heroin, cocaine, opioids, marijuana, amphetamines, inhalants, hallucinogens, benzodiazepines, zolpidem, methylphenidate, or other drugs) in the past 30 days and the number of days of use for each drug in the past 30 days. "Days of illicit drug use" was determined by counting the number of days each participant used drugs based on past-30 day self-reports at the16-week assessments.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
n=15 Participants
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Days of Illicit Drug Use
6.37 days
Standard Deviation 2.76
15.56 days
Standard Deviation 2.77

SECONDARY outcome

Timeframe: 16-weeks

Research staff asked participants if they used illicit opioids in the past 30 days and the number of days of use for each drug in the past 30 days. "Days of illicit opioid use" was determined by counting the number of days each participant used illicit opioids based on past-30 day self-reports at the 16-week assessment.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
n=15 Participants
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Days of Illicit Opioid Use
2.47 days
Standard Deviation .97
5.49 days
Standard Deviation .97

SECONDARY outcome

Timeframe: 16-weeks

Research staff assessed opioid craving with a version of the Penn Alcohol Craving Scale (PACS; Flannery et al., 1999) that was adapted to assess craving to opioids at 16-weeks. Scores range from 0 to 36. Higher scores indicate greater craving.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
n=15 Participants
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Opioid Craving
15.52 score on a scale
Standard Deviation 1.71
21.35 score on a scale
Standard Deviation 1.72

SECONDARY outcome

Timeframe: 16-weeks

Population: All randomized participants.

Pain was assess with the pain subscale (i.e., bodily pain severity and interference) of the RAND 36-Item Short Form Health Survey. Scores range from 0 to 100, with higher scores indicating better functioning, health, and well-being and less pain, limitations, and symptom severity or interference as compared to lower scores.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
n=15 Participants
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Pain Level.
50.76 score on a scale
Standard Deviation 5.52
26.65 score on a scale
Standard Deviation 5.54

SECONDARY outcome

Timeframe: 16-weeks

Depression was measured with Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D scale is a widely used valid and reliable measure that consists of 20 items with potential scores ranging from 0 to 60. A score above 16 on the CES-D indicates clinically significant symptoms of depression. Higher scores on the CES-D indicates greater depression.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
n=15 Participants
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Depression Level.
34.11 score on a scale
Standard Deviation 2.31
42.93 score on a scale
Standard Deviation 2.34

SECONDARY outcome

Timeframe: 16-weeks

Population: All randomized participants.

Anxiety was measured with the Beck Anxiety Inventory (BAI). The BAI is also a widely used, reliable, and valid scale that consists of 21 items with potential scores ranging from 0 to 63. A score of 16 or higher indicates clinically sig-nificant symptoms of anxiety. A higher score on the BAI indicates greater anxiety.

Outcome measures

Outcome measures
Measure
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
Methadone Program Behavioral Treatment as Usual
n=15 Participants
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Anxiety Level.
41.05 score on a scale
Standard Deviation 3.09
50.83 score on a scale
Standard Deviation 3.09

Adverse Events

Mindfulness Oriented Recovery Enhancement

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Methadone Program Behavioral Treatment as Usual

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nina Cooperman

Rutgers Robert Wood Johnson Medical School

Phone: 732-235-8569

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place