Trial Outcomes & Findings for Intensive Motivational Interviewing for Methamphetamine Dependence (NCT NCT01071356)

Results Overview

The proportion of days abstinent from methamphetamine was represented by univariate averages at each interview of the overall adjusted longitudinal treatment effects for each of the Standard (SMI) and Intensive (IMI) conditions. For example, a baseline average of 0.55 at baseline represents that study participants were abstinent, on average 55% of the days measured.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

217 participants

Primary outcome timeframe

Weekly while in treatment (9 weeks) and 4 and 6 month follow up

Results posted on

2018-05-24

Participant Flow

Participants were randomized using stratified permuted blocks to ensure balance by gender and meth severity (defined as 10 or more days of meth use in the past month vs. less than 10 days in the past month)

A total of 620 participants were screened for the study over the 36 month period with 563 meeting eligibility. Of the 563, 308 completed baseline assessments and 217 of them were randomized to an MI treatment condition; 91 persons completed a baseline interview but did not show up for randomization.

Participant milestones

Participant milestones
Measure	9 Sessions of Motivational Interviewing Respondents received 9 1-hour sessions of Motivational Interviewing therapy concurrent with outpatient drug treatment. Intensive Motivational Interviewing: Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education.	1 Session of Motivational Interviewing + 8 Sessions Nutrition Respondents received one 1.5-hour session of Motivational Interviewing therapy at the outset of entering outpatient drug treatment. Single session of Motivational Interviewing
Overall Study STARTED	111	106
Overall Study COMPLETED	104	97
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intensive Motivational Interviewing for Methamphetamine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	9 Sessions of Motivational Interviewing n=111 Participants Respondents received 9 1-hour sessions of Motivational Interviewing therapy concurrent with outpatient drug treatment. Intensive Motivational Interviewing: Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education.	1 Session of Motivational Interviewing + 8 Sessions Nutrition n=106 Participants Respondents received one 1.5-hour session of Motivational Interviewing therapy at the outset of entering outpatient drug treatment. Single session of Motivational Interviewing	Total n=217 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	111 Participants n=5 Participants	105 Participants n=7 Participants	216 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	38.3 years STANDARD_DEVIATION 9.7 • n=5 Participants	38.9 years STANDARD_DEVIATION 10.8 • n=7 Participants	38.6 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	53 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	53 Participants n=7 Participants	110 Participants n=5 Participants
Region of Enrollment United States	111 participants n=5 Participants	106 participants n=7 Participants	217 participants n=5 Participants

PRIMARY outcome

Timeframe: Weekly while in treatment (9 weeks) and 4 and 6 month follow up

The proportion of days abstinent from methamphetamine was represented by univariate averages at each interview of the overall adjusted longitudinal treatment effects for each of the Standard (SMI) and Intensive (IMI) conditions. For example, a baseline average of 0.55 at baseline represents that study participants were abstinent, on average 55% of the days measured.

Outcome measures

Outcome measures
Measure	9 Sessions of Motivational Interviewing n=111 Participants Respondents received 9 1-hour sessions of Motivational Interviewing therapy concurrent with outpatient drug treatment. Intensive Motivational Interviewing: Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education.	1 Session of Motivational Interviewing + 8 Sessions Nutrition n=106 Participants Respondents received one 1.5-hour session of Motivational Interviewing therapy at the outset of entering outpatient drug treatment. Single session of Motivational Interviewing
Methamphetamine Days of Abstinence : Proportion of Days Abstinent Baseline	.56 proportion of days abstinent Standard Error .04	.55 proportion of days abstinent Standard Error .04
Methamphetamine Days of Abstinence : Proportion of Days Abstinent 2 Months	.74 proportion of days abstinent Standard Error .03	.74 proportion of days abstinent Standard Error .04
Methamphetamine Days of Abstinence : Proportion of Days Abstinent 4 Months	.75 proportion of days abstinent Standard Error .03	.76 proportion of days abstinent Standard Error .03
Methamphetamine Days of Abstinence : Proportion of Days Abstinent 6 Months	.75 proportion of days abstinent Standard Error .03	.78 proportion of days abstinent Standard Error .03

SECONDARY outcome

Timeframe: Baseline, 2-,4-, and 6-month follow up

Addiction Severity Index - Lite (ASI) is a standardized, structured interview that assesses past 30 days problem severity in seven areas. These seven areas include medical, employment, drug, alcohol, legal, family/social and psychiatric status. Problem severity is rated on a scale of 0.0 - 1.0 with a higher score indicative of more problem severity. All scales have a range from 0 to 1.0.

Outcome measures

Outcome measures
Measure	9 Sessions of Motivational Interviewing n=111 Participants Respondents received 9 1-hour sessions of Motivational Interviewing therapy concurrent with outpatient drug treatment. Intensive Motivational Interviewing: Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education.	1 Session of Motivational Interviewing + 8 Sessions Nutrition n=106 Participants Respondents received one 1.5-hour session of Motivational Interviewing therapy at the outset of entering outpatient drug treatment. Single session of Motivational Interviewing
Addiction Severity Index Baseline	.27 units on a scale Standard Error .01	.26 units on a scale Standard Error .01
Addiction Severity Index 2 Months	.22 units on a scale Standard Error .01	.19 units on a scale Standard Error .01
Addiction Severity Index 4 Months	.19 units on a scale Standard Error .01	.17 units on a scale Standard Error .01
Addiction Severity Index 6 Months	.18 units on a scale Standard Error .01	.18 units on a scale Standard Error .01

Adverse Events

9 Sessions of Motivational Interviewing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1 Session of Motivational Interviewing + 8 Sessions Nutrition

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

Dr. Douglas Polcin

Public Health Institute: Alcohol Research Group

Phone: 510-597-3440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place