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

NCT04513756 | Unknown DMC

• 1 other identifier: 9048/Federal/NRPU/R&D/HEC/2017
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Conditions

Cannabis Dependence

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

• 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.

  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 Outcomes (2)

• Depression Stress and Anxiety Questionnaire

  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).

• EQ-5D-5L

  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).

Study Arms (2)

Active Treatment Group

EXPERIMENTAL

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.

Behavioral: Community Reinforcement Approach

Treatment As Usual Group

NO INTERVENTION

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.

Interventions

Community Reinforcement Approach BEHAVIORAL

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.

Active Treatment Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Islamic University, Islamabad: lead
• Pakistan Institute of Living and Learning: collaborator

Study Sites (2)

Psychological Services Clinic, Medical Center, International Islamic University

Islamabad, Federal Capital, 44000, Pakistan

Location

Research Office, Department of Psychology, International Islamic University Islamabad

Islamabad, Federal, 46000, Pakistan

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Muhammad Tahir Khalily, PhD

  International Islamic University, Islamabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychology

Study Record Dates

• First Submitted: August 9, 2020
• First Posted: August 14, 2020
• Study Start: August 18, 2019
• Primary Completion: July 30, 2021
• Study Completion: December 21, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)