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

NCT ID: NCT04513756

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-18
• Study Completion Date: 2021-12-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active Treatment Group

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.

Group Type: EXPERIMENTAL

Community Reinforcement Approach

Intervention Type: 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.

Treatment As Usual Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Community Reinforcement Approach

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pakistan Institute of Living and Learning

OTHER

Sponsor Role: collaborator

International Islamic University, Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Tahir Khalily

Professor of Clinical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad Tahir Khalily, PhD

Role: PRINCIPAL_INVESTIGATOR

International Islamic University, Islamabad

Locations

Psychological Services Clinic, Medical Center, International Islamic University

Islamabad, Federal Capital, Pakistan

Research Office, Department of Psychology, International Islamic University Islamabad

Islamabad, Federal, Pakistan

Countries

Pakistan

Other Identifiers

9048/Federal/NRPU/R&D/HEC/2017

Identifier Type: -

Identifier Source: org_study_id