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Efficacy of Community Reinforcement Approach (CRA) in the Treatment of Cannabis Users (Lifecare)

Primary Purpose

Cannabis Dependence

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Community Reinforcement Approach
Sponsored by
International Islamic University, Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Dependence

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18-30.
  2. Current, regular cannabis use, defined as the use of any cannabis product at least twice per week over the course of the past 12 months.
  3. Participant able to provide informed consent and willing to participate in the study.

Exclusion Criteria:

  1. ICD-11 dependence (in the previous 12 months) on alcohol or any other illicit drug (apart from cannabis) with symptoms of withdrawal, tolerance or craving.
  2. Current use of opiate substitution or sedative-hypnotic medication.
  3. Having been treated for cannabis use problems with any other treatment within the previous three months.
  4. Participant with lifetime psychotic disorder.
  5. Participants with moderate, severe and extremely severe scores on (DASS-21) will be excluded. Severe learning disability or a pervasive developmental disorder.
  6. Signs of severe non-cannabis-related intoxication.

Sites / Locations

  • Psychological Services Clinic, Medical Center, International Islamic University
  • Research Office, Department of Psychology, International Islamic University Islamabad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active Treatment Group

Treatment As Usual Group

Arm Description

Community Reinforcement Approach (CRA) as an intervention consisting of nine sessions (each session consists of 45-minutes). Treatment is primarily based upon the guidelines by Robert Meyers and William Miller (2001). The techniques included in the sessions are functional analysis, sobriety sampling, behavioral skills, and relapse prevention techniques.

CRA comprising of nine sessions will not be provided to this group. However, patients who will be already receiving treatment from any psychiatric or some other rehabilitation facility will be advised to continue their routine treatment.

Outcomes

Primary Outcome Measures

Time Line Follow-Back Interview (Assessing Change)
In order to gather additional information about the frequency, patterns, mode and quantity of cannabis use, we will use the Time Line Follow-Back Interview (TLFB; Sobell & Sobell, 1992) as modified by the Marijuana Treatment Project Research Group, 2004, at baseline, prior to each therapy session, at post-treatment as well as at the follow-up assessments.
The Severity of Dependence Scale (Assessing Change)
The Severity of Dependence Scale (SDS; Gossop, Darke, Griffiths, Hando, Powis, Hall, & Strang, 1995) will used to measure the degree of physical dependence the cannabis users experienced as well as the psychological components of their dependence. The scale will be used both at the time of screening and follow-ups.

Secondary Outcome Measures

Depression Stress and Anxiety Questionnaire
Depression Stress and Anxiety Questionnaire (Lovibond & Lovibond, 1995) will be used to measure depression, anxiety and stress in the participants. It is 21 item scales with 4 point rating (0-3). This scale will be used at the time of screening and follow-ups. Participants score falling in the category of severe to extremely severe will be excluded from the research at the time of screening.
EQ-5D-5L
EQ-5D-5L (EuroQol, 1990) will be used to measure participant's health related quality of life across five domains i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression on 5 levels. It also include visual analogue scale on which patient has report perceived health status on 0-100 grading.

Full Information

First Posted
August 9, 2020
Last Updated
July 19, 2021
Sponsor
International Islamic University, Islamabad
Collaborators
Pakistan Institute of Living and Learning
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1. Study Identification

Unique Protocol Identification Number
NCT04513756
Brief Title
Efficacy of Community Reinforcement Approach (CRA) in the Treatment of Cannabis Users
Acronym
Lifecare
Official Title
A Randomized Controlled Trial (RCT) to Asses the Efficacy of Community Reinforcement Approach (CRA) in the Treatment of Cannabis Users
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 18, 2019 (Actual)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
December 21, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Islamic University, Islamabad
Collaborators
Pakistan Institute of Living and Learning

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Substance abuse is not a new phenomenon in Pakistan. Its prevalence is increasing day by day due to multi-factorial reasons including psychological, cultural, biological, environmental, social and personal factors. Recent statistics shows an alarming increase in the use of substance. The last survey conducted indicates there are 3.6 million substance users in Pakistan and 3.6 percent among them are cannabis users. Furthermore, cannabis is found to be the most prevalent abused drug with adverse impact on the mental health among university students in Pakistan. However, there is a dearth of literature which could indicate a well-established treatment policy with proven efficacy model available in Pakistan. This study aims to investigate the efficacy of Community Reinforcement Approach (CRA) as evidence based remedy for Cannabis Users. The study is designed in a Randomized Controlled Trial (RCT) consisting of groups: Active Treatment (AT; with nine sessions of CRA intervention) and Treatment as Usual (TAU; routine treatment). After screening and baseline, participants will be assigned to the either Active Treatment group or Treatment As Usual group. Participants in both groups will be assessed on completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up). The primary outcome measure will be the frequency of usage, abstinence period and quantity of cannabis by using Timeline Follow Back Interview. The duration of the study is two and half years

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment Group
Arm Type
Experimental
Arm Description
Community Reinforcement Approach (CRA) as an intervention consisting of nine sessions (each session consists of 45-minutes). Treatment is primarily based upon the guidelines by Robert Meyers and William Miller (2001). The techniques included in the sessions are functional analysis, sobriety sampling, behavioral skills, and relapse prevention techniques.
Arm Title
Treatment As Usual Group
Arm Type
No Intervention
Arm Description
CRA comprising of nine sessions will not be provided to this group. However, patients who will be already receiving treatment from any psychiatric or some other rehabilitation facility will be advised to continue their routine treatment.
Intervention Type
Behavioral
Intervention Name(s)
Community Reinforcement Approach
Intervention Description
Community Reinforcement Approach (CRA) as an intervention consisting of nine sessions (each session consists of 45-minutes). Treatment is primarily based upon the guidelines by Robert Meyers and William Miller (2001). The techniques included in the sessions are functional analysis, sobriety sampling, behavioral skills, and relapse prevention techniques. The first three sessions of the intervention are based upon rapport building, induction of the rationale of CRA and Functional analysis of usage and non-usage behavior.
Primary Outcome Measure Information:
Title
Time Line Follow-Back Interview (Assessing Change)
Description
In order to gather additional information about the frequency, patterns, mode and quantity of cannabis use, we will use the Time Line Follow-Back Interview (TLFB; Sobell & Sobell, 1992) as modified by the Marijuana Treatment Project Research Group, 2004, at baseline, prior to each therapy session, at post-treatment as well as at the follow-up assessments.
Time Frame
Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
Title
The Severity of Dependence Scale (Assessing Change)
Description
The Severity of Dependence Scale (SDS; Gossop, Darke, Griffiths, Hando, Powis, Hall, & Strang, 1995) will used to measure the degree of physical dependence the cannabis users experienced as well as the psychological components of their dependence. The scale will be used both at the time of screening and follow-ups.
Time Frame
Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
Secondary Outcome Measure Information:
Title
Depression Stress and Anxiety Questionnaire
Description
Depression Stress and Anxiety Questionnaire (Lovibond & Lovibond, 1995) will be used to measure depression, anxiety and stress in the participants. It is 21 item scales with 4 point rating (0-3). This scale will be used at the time of screening and follow-ups. Participants score falling in the category of severe to extremely severe will be excluded from the research at the time of screening.
Time Frame
Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
Title
EQ-5D-5L
Description
EQ-5D-5L (EuroQol, 1990) will be used to measure participant's health related quality of life across five domains i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression on 5 levels. It also include visual analogue scale on which patient has report perceived health status on 0-100 grading.
Time Frame
Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-30. Current, regular cannabis use, defined as the use of any cannabis product at least twice per week over the course of the past 12 months. Participant able to provide informed consent and willing to participate in the study. Exclusion Criteria: ICD-11 dependence (in the previous 12 months) on alcohol or any other illicit drug (apart from cannabis) with symptoms of withdrawal, tolerance or craving. Current use of opiate substitution or sedative-hypnotic medication. Having been treated for cannabis use problems with any other treatment within the previous three months. Participant with lifetime psychotic disorder. Participants with moderate, severe and extremely severe scores on (DASS-21) will be excluded. Severe learning disability or a pervasive developmental disorder. Signs of severe non-cannabis-related intoxication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Tahir Khalily, PhD
Organizational Affiliation
International Islamic University, Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychological Services Clinic, Medical Center, International Islamic University
City
Islamabad
State/Province
Federal Capital
ZIP/Postal Code
44000
Country
Pakistan
Facility Name
Research Office, Department of Psychology, International Islamic University Islamabad
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Community Reinforcement Approach (CRA) in the Treatment of Cannabis Users

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