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Intensive Motivational Interviewing for Methamphetamine Dependence

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ClinicalTrials.gov Identifier: NCT01071356
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : May 24, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Alcoholresearchgroup, Public Health Institute, California

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Methamphetamine Dependence
Interventions: Behavioral: Intensive MI
Behavioral: Single session MI

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    9 Sessions of Motivational Interviewing   1 Session of Motivational Interviewing + 8 Sessions Nutrition
STARTED   111   106 
COMPLETED   104   97 
NOT COMPLETED   7   9 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   9 Sessions of Motivational Interviewing   1 Session of Motivational Interviewing + 8 Sessions Nutrition   Total 
Overall Participants Analyzed 
[Units: Participants]
 111   106   217 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      111 100.0%      105  99.1%      216  99.5% 
>=65 years      0   0.0%      1   0.9%      1   0.5% 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.3  (9.7)   38.9  (10.8)   38.6  (10.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      54  48.6%      53  50.0%      107  49.3% 
Male      57  51.4%      53  50.0%      110  50.7% 
Region of Enrollment 
[Units: Participants]
     
United States   111   106   217 


  Outcome Measures

1.  Primary:   Methamphetamine Days of Abstinence : Proportion of Days Abstinent   [ Time Frame: Weekly while in treatment (9 weeks) and 4 and 6 month follow up ]

2.  Secondary:   Addiction Severity Index   [ Time Frame: Baseline, 2-,4-, and 6-month follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Douglas Polcin
Organization: Public Health Institute: Alcohol Research Group
phone: 510-597-3440 ext 277
e-mail: dpolcin@arg.org


Publications:
Martino S, Ball SA, Gallon SL, et al. Motivational Interviewing Assessment: Supervisory tools for enhancing proficiency Salem, OR: Northwest Frontier Addiction Technology Transfer Center, Oregon Health and Science University. 2006 [Accessed: 2013-02-05. Archived by WebCite® at http://www.webcitation.org/6EDD4BNKM];
Polcin DL. Reexamining confrontation and Motivational Interviewing. Addict Disord Their Treat 2006;5:201-9.
Polcin DL, Brown M, Galloway GP. Intensive Motivational Enhancement Therapy Manual. Berkeley, CA: Alcohol Research Group; 2005.


Responsible Party: Alcoholresearchgroup, Public Health Institute, California
ClinicalTrials.gov Identifier: NCT01071356     History of Changes
Other Study ID Numbers: 1R01DA024714 ( U.S. NIH Grant/Contract )
First Submitted: February 17, 2010
First Posted: February 19, 2010
Results First Submitted: May 11, 2015
Results First Posted: May 24, 2018
Last Update Posted: May 24, 2018